| Reference |
Title |
Publication date
|
MDCG 2021-26
MDCG 2021-25
MDCG 2019-6 v3
|
Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Regulation (EU) 2017/745 - 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
Questions and answers: Requirements relating to notified bodies
|
November 2021 |
| MDCG 2021-24 |
Guidance on classification of medical devices |
October 2021 |
| Helsinki Procedure |
Helsinki Procedure for borderline and classification under MDR & IVDR |
October 2021 |
| MDCG 2021-23 |
Guidance for notified bodies, distributors and importers onClarification 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 |
August 2021 |
| 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 |
August 2021 |
| MDCG 2021-21 |
Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices |
August 2021 |
| MDCG 2021-20 |
Instructions for generating CIV-ID for MDR Clinical Investigations |
July 2021 |
| MDCG 2021-19 |
Guidance note integration of the UDI within an organisation’s quality management system |
July 2021 |
| MDCG 2021-18 |
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) |
July 2021 |
| MDCG 2021-17 |
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) |
July 2021 |
| 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) |
July 2021 |
| 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) |
July 2021 |
| MDCG 2021-14 |
Explanatory note on IVDR codes |
July 2021 |
| MDCG 2021-13 rev. 1.0 |
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 |
July 2021 |
| MDCG 2021-12 |
FAQ on the European Medical Device Nomenclature (EMDN) |
May 2021 |
| MDCG 2021-11 |
Guidance on Implant Card – Device types |
May 2021 |
| MDCG 2021-10 |
The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices |
May 2021 |
| MDCG 2021-9 |
MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers |
May 2021 |
| MDCG 2021-8 |
Clinical investigation application/notification documents |
May 2021 |
| MDCG 2021-7 |
Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices |
May 2021 |
| MDCG 2021-6 |
Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation |
May 2021 |
| MDCG 2021-5 |
Guidance on standardisation for medical devices |
April 2021 |
| MDCG 2021-4 |
Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 |
April 2021 |
| MDCG 2021-3 |
Questions and Answers on Custom-Made Devices |
March 2021 |
| MDCG 2021-2 |
Guidance on state of the art of COVID-19 rapid antibody tests |
March 2021 |
| MDCG 2021-1 |
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional |
Febraury 2021 |
| MDCG 2020-18 |
MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers |
December 2020 |
| 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” |
December 2020 |
| MDCG 2020-16 |
Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 |
November 2020 |
| 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 |
August 2020 |
| 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) |
August 2020 |
| MDCG 2020-13 |
Clinical evaluation assessment report template |
July 2020 |
| 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 |
June 2020 |
| MDCG 2020-11 |
Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 |
May 2020 |
| MDCG 2020-10-2 |
Clinical Investigation Summary Safety Report Form v1.0 |
May 2020 |
| MDCG 2020-10-1 |
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 |
May 2020 |
| MDCG 2020-9 |
Regulatory requirements for ventilators and related accessories |
April 2020 |
| MDCG 2020-8 |
Post-market clinical follow-up (PMCF) Evaluation Report Template |
April 2020 |
| MDCG 2020-7 |
Post-market clinical follow-up (PMCF) Plan Template |
April 2020 |
| MDCG 2020-6 |
Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC |
April 2020 |
| MDCG 2020-5 |
Clinical Evaluation - Equivalence |
April 2020 |
| MDCG 2020-4 |
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions |
April 2020 |
| 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 |
March 2020 |
| MDCG 2020-2 |
Class I Transitional provisions under Article 120 (3 and 4) – (MDR) |
March 2020 |
| MDCG 2020-1 |
Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software |
March 2020 |
| MDCG 2019-16 |
Guidance on Cybersecurity for medical devices |
December 2019 |
| MDCG 2019-15 |
Guidance notes for manufacturers of class I medical devices |
December 2019 |
| MDCG 2019-14 |
Explanatory note on MDR codes |
December 2019 |
| MDCG 2019-13 |
MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation |
December 2019 |
| MDCG 2019-12 |
Designating authority's final assessment form: Key information (EN) |
October 2019 |
| MDCG 2019-11 |
Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 |
October 2019 |
| MDCG 2019-10 |
Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC |
October 2019 |
| MDCG 2019-9 |
MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies |
September 2019 |
| MDCG 2019-8 v2 |
Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices |
March 2020 |
| MDCG 2019-8 |
Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices |
July 2019 |
| MDCG 2019-7 |
Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC) |
June 2019 |
| MDCG 2019-6 |
Questions and answers: Requirements relating to notified bodies |
June 2019 |
| MDCG 2019-5 |
Registration of legacy devices in EUDAMED |
April 2019 |
| MDCG 2019-4 |
Timelines for registration of device data elements in EUDAMED |
April 2019 |
| MDCG 2019-3 |
Interpretation of Article 54(2)b Rev.1 |
April 2020 |
| 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 |
Febraury 2019 |
| MDCG 2019-1 |
MDCG guiding principles for issuing entities rules on Basic UDI-DI |
January 2019 |
| MDCG 2018-1 v3 |
Guidance on BASIC UDI-DI and changes to UDI-DI |
March 2020 |
| MDCG 2018-1 |
Draft guidance on basic UDI-DI and changes to UDI-DI |
March 2018 |
| MDCG 2018-2 |
Future EU medical device nomenclature – Description of requirements |
March 2018 |
| MDCG 2018-3 |
Guidance on UDI for systems and procedure packs |
October 2018 |
| MDCG 2018-4 |
Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs |
October 2018 |
| MDCG 2018-5 |
UDI Assignment to Medical Device Software |
October 2018 |
| MDCG 2018-6 |
Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation (EU) 2017/745 and the In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746 |
October 2018 |
| MDCG 2018-7 |
Provisional considerations regarding language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Device Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR)) |
October 2018 |
| MDCG 2018-8 |
Guidance on content of the certificates, voluntary certificate transfers |
November 2018 |
