Liste und Dokumentation der Prüfung auf Aktualität der relevanten Normen, Gesetzte, Richtlinien, Verordnungen, Leitlinien etc.
| Nr. | DIN EN ISO | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|---|
| 1041 | DIN EN | Bereitstellung von Informationen durch den Hersteller von Medizinprodukten; Deutsche Fassung EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices | 2013-12 | - |
| 13485 | DIN EN ISO | Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016); Deutsche Fassung EN ISO 13485:2016 + AC:2018 + A11:2021 | 2021-12 | ✔ |
| 13485 | DIN EN ISO C1 / B1 | Medizinprodukte, Qualitätsmanagementsysteme, Anforderungen für regulatorische Zwecke, Berichtigung 1 (ISO 13485:2016); Deutsche Fassung EN ISO 13485:2016, Berichtigung zu DIN EN ISO 13485:2016-08; Deutsche Fassung EN ISO 13485:2016/AC:2016 Medical devices - Quality management systems - Requirements for regulatory purposes, Corrigendum 1 (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016 | 2017-07 | - |
| 13485 | DIN EN ISO | Medizinprodukte, Qualitätsmanagementsysteme, Anforderungen für regulatorische Zwecke (ISO 13485:2016); Deutsche Fassung EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); Deutsche Fassung EN ISO 13485:2016 | 2016-08 | - |
| 14971 | DIN EN ISO | Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2019); Deutsche Fassung EN ISO 14971:2019 + A11:2021 | 2022-04 | ✔ |
| 14971 | DIN EN ISO | Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2019); | 2020-07 | - |
| 19011 | DIN EN ISO | Leitfaden zur Auditierung von Managementsystemen (ISO 19011:2018) | 2018-10 | ✔ |
| 19011 | DIN EN ISO | Leitfaden zur Auditierung von Managementsystemen (ISO/DIS 19011:2025); Deutsche und Englische Fassung prEN ISO 19011:2025 | 2025-04 | E |
| 20417 | DIN EN ISO | Medizinprodukte - Anforderungen an vom Hersteller bereitzustellende Informationen (ISO 20417:2021, korrigierte Fassung 2021-12); Deutsche Fassung EN ISO 20417:2021 | 2022-03 | ✔ |
| 20417 | DIN EN ISO | Medizinprodukte - Anforderungen an vom Hersteller bereitzustellende Informationen (ISO/DIS 20417:2024); Deutsche und Englische Fassung prEN ISO 20417:2024 | 2024-12 | E |
| 24971 | ISO/TR | Medizinprodukte - Leitfaden für die Anwendung von ISO 14971 | 2020-06 | ✔ |
| 27001 | DIN EN ISO/IEC | Informationssicherheit, Cybersicherheit und Datenschutz - Informationssicherheitsmanagementsysteme - Anforderungen (ISO/IEC 27001:2022); Deutsche Fassung EN ISO/IEC 27001:2023 Information security, cybersecurity and privacy protection - Information security management systems - Requirements (ISO/IEC 27001:2022); German version EN ISO/IEC 27001:2023 | 2024-01 | K |
| 27001 | DIN EN ISO/IEC | Informationstechnik - Sicherheitsverfahren - Informationssicherheitsmanagementsysteme - Anforderungen (ISO/IEC 27001:2013 einschließlich Cor 1:2014 und Cor 2:2015); | 2017-06 | - |
| 62304 | DIN EN VDE 0750-101 | Medizingeräte-Software - Software-Lebenszyklus-Prozesse (IEC 62304:2006 + A1:2015); Deutsche Fassung EN 62304:2006 + Cor.:2008 + A1:2015 Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015) | 2016-10 | ✔ |
| 62304 | E-DIN prEN VDE 0750-101-Entwurf | Medizingeräte-Software - Software-Lebenszyklus-Prozesse (IEC 62A/1235/CDV:2018); Deutsche und Englische Fassung prEN 62304:2018 Health software - Software life cycle processes (IEC 62A/1235/CDV:2018) | 2018-06 | - |
| 62366-1 0750-241-1 | DIN EN VDE | Medizinprodukte - Teil 1: Anwendung der Gebrauchstauglichkeit auf Medizinprodukte (IEC 62366-1:2015 + COR1:2016 + A1:2020); Deutsche Fassung EN 62366-1:2015 + AC:2015 + A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020 | 2021-08 | ✔ |
| 62366-1 0750-241-1 | DIN EN VDE | Medizinprodukte - Teil 1: Anwendung der Gebrauchstauglichkeit auf Medizinprodukte (IEC 62366-1:2015 + COR1:2016); Deutsche Fassung EN 62366-1:2015 + AC:2015 Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016); German version EN 62366-1:2015 + AC:2015 | 2017-07 | - |
| IEC 81001-5-1 | IEC | Anwendung des Risikomanagements für IT-Netzwerke, die Medizinprodukte beinhalten - Sicherheit, Effektivität und Daten- und Systemsicherheit bei Implementierung und Gebrauch von eingebundenen Medizinprodukten oder eingebundener Gesundheitssoftware - Teil 5-1: Aktivitäten im Produktlebenszyklus | 2021-12 | ✔ |
| DIN EN 82304-1 | DIN EN VDE | Gesundheitssoftware - Teil 1: Allgemeine Anforderungen für die Produktsicherheit (IEC 82304-1:2016); Deutsche Fassung EN 82304-1:2017 | 2018-04 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | ||||
Bemerkungen:
| Nr. / Code | Bezeichnung / Titel | veröffentlicht | JJJJ-MM | Status |
|---|---|---|---|---|
| 2017/475 MDR | VERORDNUNG (EU) 2017/745 DES EUROPÄISCHEN PARLAMENTS UND DES RATES vom 5. April 2017 über Medizinprodukte, wirksam ab 2020-05-26 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC | 2017-04-05 | 2017-04-05 | ✔ |
| 2017/475 MDR Berichtigung | Berichtigung der Verordnung (EU) 2017/745 des Europäischen Parlaments und des Rates vom 5. April 2017 über Medizinprodukte, zur Änderung der Richtlinie 2001/83/EG, der Verordnung (EG) Nr. 178/2002 und der Verordnung (EG) Nr. 1223/2009 und zur Aufhebung der Richtlinien 90/385/EWG und 93/42/EWG des Rates | 2017-04-05 | 2019-05-03 | ✔ |
| MPEUAnpG | Gesetz zur Anpassung des Medizinprodukterechts an die Verordnung (EU) 2017/745 und die Verordnung (EU) 2017/746 (Medizinprodukte-EU-Anpassungsgesetz – MPEUAnpG) | 2020-04-28 | 2020-04-28 | ✔ |
| MPDG | Gesetz zur Durchführung unionsrechtlicher Vorschriften betreffend Medizinprodukte (Medizinprodukterecht-Durchführungsgesetz – MPDG) | 2020-04-28 | 2020-04-28 | ✔ |
| MPEUAnpV | Verordnung zur Anpassung des Medizinprodukterechts an die Verordnung (EU) 2017/745 und die Verordnung (EU) 2017/746 (Medizinprodukte-EU-Anpassungsverordnung – MPEUAnpV) | 2021-04-21 | 2021-04-21 | ✔ |
| MPBetreibV | Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten (Medizinprodukte-Betreiberverordnung - MPBetreibV) | 1998-06-29 | 2018-11-29 | ✔ |
| MEDDEV 2.7/1 | CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC, rev. 4 | - | 2016-06 | ✔ |
| DGUV V1 | Grundsätze der Prävention | - | 2013 | ✔ |
| DGUV V3 | Elektrische Anlagen und Betriebsmittel | 1979-04-01 | 1997-01-01 | ✔ |
| DIMDIV | Verordnung über das datenbankgestützte Informationssystem über Medizinprodukte des Deutschen Instituts für Medizinische Dokumentation und Information Ordinance on databased supported information system on medical devices of the German Institute for Medicinal Documentation and Information | 2002-12 | 2018-11-29 | - |
| 93/42/EWG MDD 93/42/EEC | Richtlinie 93/42/EWG des Rates vom 14. Juni 1993 über Medizinprodukte, zuletzt geändert durch Artikel 2 der Richtlinie 2007/47/EG des Europäischen Parlaments und des Rates vom 5. September 2007 COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, Amended by: Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 | 1993-06 | 2007-09-05 | - |
| MPG | Gesetz über Medizinprodukte (Medizinproduktegesetz - MPG) Act on medical devices | 1994-08 | 2017-07-18 | - |
| MPSV | Verordnung über die Erfassung, Bewertung und Abwehr von Risiken bei Medizinprodukten Ordinance on Detection, Evaluation and Prevention of Risks connected with Medical Devices (Medical Devices Safety Plan Ordinance), (Ordinance on the Medical Devices Vigilance System) | 2002-06 | 2018-11-29 | - |
| MPV | Verordnung über Medizinprodukte Ordinance on medical devices | 2001-12 | 2016-09-27 | - |
| MEDDEV 2.12/1 | GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM, Rev. 8 | - | 2013-01 | - |
| Ad MEDDEV 2.12/1 | Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8 | 2019-05-07 | 2019-05-07 | - |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | ||||
Bemerkungen:
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2023-6 | Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies | 2023-12 | ✔ |
| MDCG 2023-5 | Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies | 2023-12 | ✔ |
| Q&A | Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR | 2023-09 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| Manual on Borderline | Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v4 | 2025-09 | ✔ |
| Manual on Borderline | Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3 | 2023-09 | - |
| Manual on Borderline | Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v2 | 2022-12 | - |
| MDCG 2024-13 | Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices | 2024-10 | ✔ |
| MDCG 2022-5 rev.1 | Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices | 2024-10 | ✔ |
| MDCG 2022-5 | Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices | 2022-04 | - |
| MDCG 2021-24 | Guidance on classification of medical devices | 2021-10 | ✔ |
| Helsinki Procedure | Helsinki Procedure for borderline and classification under MDR & IVDR | 2021-09 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2020-2 rev.1 | Class I transitional provisions under Article 120 (3 and 4) – (MDR) | 2020-03 | ✔ |
| MDCG 2019-15 rev.1 | Guidance notes for manufacturers of class I medical devices | 2019-12 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2025-5 | Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 | 2025-06 | ✔ |
| MDCG 2024-15 | Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED | 2024-11 | ✔ |
| MDCG 2024-10 | Clinical evaluation of orphan medical devices | 2024-06 | ✔ |
| MDCG 2024-5 | Guidance on the Investigator’s Brochure content | 2024-04 | ✔ |
| MDCG 2024-5 Appendix A | Appendix A of the MDCG 2024-5 | 2024-04 | ✔ |
| MDCG 2024-3 | Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices | 2024-03 | ✔ |
| MDCG 2024-3 Appendix A | Clinical Investigation Plan Synopsis Template | 2024-03 | ✔ |
| MDCG 2023-7 | Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence | 2023-12 | ✔ |
| 2023/C 163/06 | Commission Guidance on the content and structure of the summary of the clinical investigation report | 2023-05 | ✔ |
| MDCG 2021-28 | Substantial modification of clinical investigation under Medical Device Regulation | 2021-12 | ✔ |
| MDCG 2021-20 | Instructions for generating CIV-ID for MDR Clinical Investigations | 2021-07 | ✔ |
| MDCG 2021-8 | Clinical investigation application/notification documents | 2021-05 | ✔ |
| MDCG 2021-6 | Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation | 2021-04 | - |
| MDCG 2021-6 - Rev.1 | Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation | 2023-12 | ✔ |
| MDCG 2020-13 | Clinical evaluation assessment report template | 2020-07 | ✔ |
| MDCG 2020-10/1 | Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form | 2020-05 | - |
| MDCG 2020-10/1 Rev.1 | Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form | 2022-10 | ✔ |
| MDCG 2020-10/2 | Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form | 2020-05 | - |
| MDCG 2020-10/2 Rev.1 | Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form | 2022-10 | ✔ |
| MDCG 2020-8 | Guidance on PMCF evaluation report template | 2020-04 | ✔ |
| MDCG 2020-7 | Guidance on PMCF plan template | 2020-04 | ✔ |
| MDCG 2020-6 | Guidance on sufficient clinical evidence for legacy devices | 2020-04 | ✔ |
| MDCG 2020-5 | Guidance on clinical evaluation – Equivalence | 2020-04 | ✔ |
| MDCG 2019-9 | Summary of safety and clinical performance | 2019-08 | - |
| MDCG 2019-9 - Rev.1 | Summary of safety and clinical performance | 2022-03 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2022-1 | Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices | 2022-01 | ✔ |
| MDCG 2021-21 Rev.1 | Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices | 2022-02 | ✔ |
| MDCG 2021-7 | Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices | 2021-05 | ✔ |
| MDCG 2021-2 | Guidance on state of the art of COVID-19 rapid antibody tests | 2021-03 | ✔ |
| - | COVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 | 2021-02 | ✔ |
| - | Conformity assessment procedures for protective equipment | 2020-07 | ✔ |
| - | How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context | 2020-05 | ✔ |
| - | Guidance on regulatory requirements for medical face masks | 2020-06 | ✔ |
| - | Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context | 2020-04 | ✔ |
| - | Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19 | 2020-04 | ✔ |
| MDCG 2020-9 | Regulatory requirements for ventilators and related accessories | 2020-04 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2021-3 | Questions and Answers on Custom-Made Devices | 2021-03 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| Gradual roll out of EUDAMED | Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices1 | 2024-11 | ✔ |
| MDCG 2022-12 | Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) | 2022-07 | ✔ |
| MDCG 2021-13 Rev. 1 | Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR | 2021-07 | ✔ |
| MDCG 2021-1 Rev. 1 | Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional | 2021-05 | ✔ |
| MDCG 2020-15 | MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States | 2020-08 | ✔ |
| MDCG 2019-5 | Registration of legacy devices in EUDAMED | 2019-04 | ✔ |
| MDCG 2019-4 | Timelines for registration of device data elements in EUDAMED | 2019-04 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2025-3 | EMDN Version History | 2025-01 | ✔ |
| MDCG 2025-2 | Summary of EMDN 2024 Submissions and outcome of annual revision | 2025-01 | ✔ |
| MDCG 2025-1 | EMDN Ad hoc procedure | 2025-01 | ✔ |
| MDCG 2024-2 rev.1 | Procedures for the updates of the EMDN | 2025-01 | ✔ |
| MDCG 2024-2 | Procedures for the updates of the EMDN | 2024-02 | - |
| MDCG 2021-12 rev.1 | FAQ on the European Medical Device Nomenclature (EMDN) | 2025-01 | ✔ |
| MDCG 2021-12 | FAQ on the European Medical Device Nomenclature (EMDN) | 2021-06 | - |
| - | The EMDN – The nomenclature of use in EUDAMED | 2020-01 | ✔ |
| - | The CND nomenclature – Background and general principles | 2020-01 | ✔ |
| MDCG 2018-2 | Future EU medical device nomenclature - Description of requirements | 2018-03 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2021-11 | Guidance on Implant Card – Device types | 2021-05 | ✔ |
| MDCG 2019-8 v2 | Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices | 2020-03 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2023-1 | Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 2023-01 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2022-16 | Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 2022-10 | ✔ |
| MDCG 2021-27 | Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 2021-12 | - |
| MDCG 2021-27 - Rev.1 | Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 2023-12 | ✔ |
| MDCG 2021-26 | Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 2021-10 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| Q&A rev.1 | Q&A Obligation to inform in case of interruption or discontinuation of supply | 2024-12 | ✔ |
| MDCG 2024-16 | Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices | 2024-12 | ✔ |
| MDCG 2024-16 Annex | Device Identification table | 2024-12 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2024-11 | Guidance on qualification of in vitro diagnostic medical devices | 2024-10 | ✔ |
| MDCG 2024-4 | Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 | 2024-04 | ✔ |
| MDCG 2024-4 Appendix | Appendix – Performance Study Summary Safety Reporting Form | 2024-04 | ✔ |
| MDCG 2022-20 | Substantial modification of performance study under Regulation (EU) 2017/746 | 2022-12 | ✔ |
| MDCG 2022-19 | Performance study application/notification documents under Regulation (EU) 2017/746 | 2022-12 | ✔ |
| MDCG 2022-15 | Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD | 2022-09 | ✔ |
| MDCG 2021-22 | Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 | 2021-08 | - |
| MDCG 2021-22 rev.1 | Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 | 2022-09 | ✔ |
| MDCG 2022-10 | Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) | 2022-05 | ✔ |
| MDCG 2022-9 | Summary of safety and performance template | 2022-05 | - |
| MDCG 2022-9 rev.1 | Summary of safety and performance template | 2024-04 | ✔ |
| MDCG 2022-8 | Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC | 2022-05 | ✔ |
| MDCG 2022-6 | Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR | 2022-05 | ✔ |
| MDCG 2022-3 | Verification of manufactured class D IVDs by notified bodies | 2022-02 | - |
| MDCG 2022-3 rev.1 | Verification of manufactured class D IVDs by notified bodies | 2024-12 | ✔ |
| MDCG 2022-2 | Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) | 2022-01 | ✔ |
| MDCG 2021-4 | Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 | 2021-04 | - |
| MDCG 2021-4 rev.1 | Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 | 2024-09 | ✔ |
| MDCG 2020-16 Rev.1 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | 2022-01 | - |
| MDCG 2020-16 Rev.2 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | 2023-02 | - |
| MDCG 2020-16 rev.3 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | 2024-07 | - |
| MDCG 2020-16 rev.4 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | 2025-03 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2025-9 | Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746 | 2025-12 | ✔ |
| MDCG 2025-6 | FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) | 2025-06 | ✔ |
| MDCG 2025-4 | Guidance on the safe making available of medical device software (MDSW) apps on online platforms | 2025-06 | ✔ |
| MDCG 2023-4 | Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components | 2023-10 | ✔ |
| Infographic | Is your software a Medical Device? | 2021-03 | ✔ |
| MDCG 2020-1 | Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software | 2020-03 | ✔ |
| MDCG 2019-16 rev.1 | Guidance on cybersecurity for medical devices | 2019-12 | ✔ |
| MDCG 2019-11 rev.1 | Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 2025-06 | ✔ |
| MDCG 2019-11 | Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 2019-10 | - |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2024-6 | Preliminary re-assessment review (PRAR) form template (MDR) | 2024-05 | ✔ |
| MDCG 2024-7 rev.1 | Preliminary assessment review (PAR) form template (MDR) | 2025-01 | ✔ |
| MDCG 2021-15/MDCG 2024-7 Annex | Annex to Application Form & PAR Template MDR (List of documents) | 2025-01 | ✔ |
| MDCG 2024-8 rev.1 | Preliminary assessment review (PAR) form template (IVDR) | 2025-01 | ✔ |
| MDCG 2021-16/MDCG 2024-8 Annex | Annex to Application Form & PAR Template IVDR (List of documents) | 2025-01 | ✔ |
| MDCG 2024-9 | Preliminary re-assessment review (PRAR) form template (IVDR) | 2024-05 | ✔ |
| MDCG 2020-3 | Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD | 2020-03 | - |
| MDCG 2020-3 Rev.1 | Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD | 2023-09 | ✔ |
| MDCG 2023-2 | List of Standard Fees | 2023-01 | ✔ |
| MDCG 2022-4 | Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD | 2022-02 | - |
| MDCG 2022-4 rev.1 | Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD | 2022-12 | - |
| MDCG 2022-4 rev.2 | Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD | 2024-05 | ✔ |
| MDCG 2022-17 | MDCG position paper on „hybrid audits“ | 2022-12 | ✔ |
| MDCG 2019-6 Rev.3 | Questions and answers: Requirements relating to notified bodies | 2021-10 | - |
| MDCG 2019-6 Rev.4 | Questions and answers: Requirements relating to notified bodies | 2022-10 | - |
| MDCG 2019-6 rev.5 | Questions and answers: Requirements relating to notified bodies | 2025-02 | ✔ |
| MDCG 2022-13 | Designation, re-assessment and notification of conformity assessment bodies and notified bodies | 2022-08 | - |
| MDCG 2022-13 rev.1 | Designation, re-assessment and notification of conformity assessment bodies and notified bodies | 2024-06 | ✔ |
| MDCG 2024-12 | Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams | 2024-10 | ✔ |
| MDCG 2024-12 Annex I Form | Annex I: Template CAPA plan and assessment thereon | 2024-10 | ✔ |
| MDCG 2024-12 Annex II Form | Annex II: Template JAT review of the CAPA and the DA's opinion | 2024-10 | ✔ |
| MDCG 2021-23 | Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 2021-08 | ✔ |
| MDCG 2021-18 | Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) | 2021-07 | ✔ |
| MDCG 2021-17 | Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) | 2021-07 | - |
| MDCG 2021-17 | Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) | 2025-01 | ✔ |
| MDCG 2021-16 | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) | 2021-07 | - |
| MDCG 2021-16 rev.1 | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) | 2025-01 | ✔ |
| MDCG 2021-16/MDCG 2024-8 Annex | Annex to Application Form & PAR Template IVDR (List of documents) | 2025-01 | ✔ |
| MDCG 2021-15 | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) | 2021-07 | - |
| MDCG 2021-15 rev.1 | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) | 2025-01 | ✔ |
| MDCG 2021-15/MDCG 2024-7 Annex | Annex to Application Form & PAR Template MDR (List of documents) | 2025-01 | ✔ |
| MDCG 2021-14 | Explanatory note on IVDR codes | 2021-07 | ✔ |
| MDCG 2020-17 | Questions and Answers related to MDCG 2020-4: “Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions” | 2020-12 | ✔ |
| MDCG 2020-14 | Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) | 2020-08 | ✔ |
| MDCG 2020-12 | Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues | 2020-06 | ✔ |
| MDCG 2020-11 | Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013 | 2020-05 | ✔ |
| MDCG 2020-4 | Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions | 2020-04 | ✔ |
| MDCG 2019-14 | Explanatory note on MDR codes | 2019-12 | ✔ |
| MDCG 2019-13 | Guidance on sampling of devices for the assessment of the technical documentation | 2019-12 | - |
| MDCG 2019-13 rev.1 | Guidance on sampling of devices for the assessment of the technical documentation | 2024-12 | ✔ |
| MDCG 2019-12 | Designating authority's final assessment form: Key information (EN) | 2019-10 | ✔ |
| MDCG 2019-10 rev.1 | Application of transitional provisions concerning validity of certificates issued in accordance to the directives | 2019-10 | ✔ |
| MDCG 2018-8 | Guidance on content of the certificates, voluntary certificate transfers | 2018-11 | ✔ |
| NBOG BPG 2017-1 | Best practice guidance on designation and notification of conformity assessment bodies | 2018-02 | - |
| NBOG BPG 2017-2 | Best practice guidance on the information required for personnel involved in conformity assessment | 2018-02 | ✔ |
| NBOG F 2017-8 | Review of qualification for the authorisation of personnel (IVDR) | 2018-02 | ✔ |
| NBOG F 2017-7 | Review of qualification for the authorisation of personnel (MDR) | 2018-02 | ✔ |
| NBOG F 2017-6 | Preliminary assessment review template (IVDR) | 2018-02 | - |
| NBOG F 2017-5 | Preliminary assessment review template (MDR) | 2018-02 | - |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2019-7 - Rev.1 | Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) | 2023-12 | ✔ |
| MDCG 2019-7 | Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) | 2019-06 | - |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2025–10 | Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices | 2025-12 | ✔ |
| MDCG 2024-1 | Device Specific Vigilance Guidance (DSVG) Template | 2024-01 | ✔ |
| MDCG 2024-1-1 | DSVG 01 on Cardiac ablation | 2024-01 | ✔ |
| MDCG 2024-1-2 | DSVG 02 on Coronary stents | 2024-01 | ✔ |
| MDCG 2024-1-3 | DSVG 03 on Cardiac implantable electronic devices (CIEDs) | 2024-01 | ✔ |
| MDCG 2024-1-4 | DSVG 04 on Breast implants | 2024-01 | ✔ |
| MDCG 2024-1-5 | DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence | 2024-06 | ✔ |
| MDCG 2023-3 | Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices | 2023-02 | - |
| MDCG 2023-3 rev.2 | Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 | 2025-01 | ✔ |
| MDCG 2022-21 | Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 | 2022-12 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2021-5 | Guidance on standardisation for medical devices | 2021-04 | - |
| MDCG 2021-5 rev.1 | Guidance on standardisation for medical devices | 2024-06 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDCG 2025-8 | Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles | 2025-11 | ✔ |
| MDCG 2025-7 Rev. 1 | MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles | 2025-12 | ✔ |
| MDCG 2024-14 | Guidance on the implementation of the Master UDI-DI solution for contact lenses | 2024-11 | - |
| MDCG 2024-14 - rev.1 | Guidance on the implementation of the Master UDI-DI solution for contact lenses | 2025-08 | ✔ |
| MDCG 2022-7 | Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) | 2022-05 | ✔ |
| MDCG 2021-19 | Guidance note integration of the UDI within an organisation’s quality management system | 2021-07 | ✔ |
| MDCG 2021-10 | The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices | 2021-06 | ✔ |
| MDCG 2021-09 | MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers | 2021-05 | ✔ |
| MDCG 2018-1 Rev. 4 | Guidance on basic UDI-DI and changes to UDI-DI | 2021-04 | ✔ |
| MDCG 2020-18 | MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers | 2020-12 | ✔ |
| MDCG 2019-2 | Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017 | 2019-02 | ✔ |
| MDCG 2019-1 | MDCG guiding principles for issuing entities rules on basic UDI-DI | 2019-01 | ✔ |
| MDCG 2018-7 | Provisional considerations regarding language issues associated with the UDI database | 2018-10 | ✔ |
| MDCG 2018-6 | Clarifications of UDI related responsibilities in relation to article 16 | 2018-10 | ✔ |
| MDCG 2018-5 | UDI assignment to medical device software | 2018-10 | ✔ |
| MDCG 2018-4 | Definitions/descriptions and formats of the UDI core elements for systems or procedure packs | 2018-10 | ✔ |
| MDCG 2018-3 Rev.1 | Guidance on UDI for systems and procedure packs | 2020-06 | ✔ |
| MDCG 2018-1 v3 | Guidance on basic UDI-DI and changes to UDI-DI | 2020-03 | - |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| Q&A | Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 | 2024-07 | ✔ |
| MDCG 2022-11 - Rev.1 | MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements | 2023-11 | ✔ |
| MDCG 2022-11 | MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements | 2022-06 | - |
| Q&A Rev. 1 | Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods | 2023-07 | - |
| Q&A rev.2 | Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods | 2024-07 | ✔ |
| MDCG 2022-18 ADD.1 | MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - Addendum 1 | 2023-06 | ✔ |
| MDCG 2022-18 | MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate | 2022-12 | ✔ |
| MDCG 2022-14 | Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs | 2022-08 | ✔ |
| MDCG 2021-25 | Application of MDR requirements to „legacy devices“ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC | 2021-10 | - |
| MDCG 2021-25 rev.1 | Application of MDR requirements to „legacy devices“ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC | 2024-10 | ✔ |
| MDCG 2019-3 rev.1 | Interpretation of article 54(2)b | 2020-04 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||
| Nr. / Code | Bezeichnung / Titel | JJJJ-MM | Status |
|---|---|---|---|
| MDR/IVDR Language requirements | Overview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific country | 2024-01 | ✔ |
| European Medicines Agency (EMA) Guidance | Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) | 2021-06 | ✔ |
| SCHEER guidelines | Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties | 2019-06 | - |
| SCHEER guidelines | Update on the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties | 2024-06 | ✔ |
| CAMD FAQ | CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions | 2018-01 | ✔ |
| Legende: ✔ = aktuell, OK; E = Entwurf; F = noch in der Frist (Übergangsfrist); - = alt; K = kaufen, beschaffen, noch nicht im Bestand | |||