Medical Devices - December 2022 Newsletter
 

Newsletter  December 2022

For more information and regular updates please consult our website HERE.

As we continue our efforts to support the implementation of the new Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), we aim to keep you up to date on all relevant news and events. In this issue of our newsletter, we have updates on common specifications, Eudamed, borderline and classification, in vitro diagnostics, notified bodies, the latest available guidance, and much more!  

In this issue

•  Common specifications for Annex XVI products and reclassification

•  Eudamed information centre

•  Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746

•  Revision of MDCG 2021-22 Guidance on 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

•  New revision of MDCG 2019-6 Questions and answers on requirements relating to notified bodies

•  Revision of 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

•  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

•  MDCG 2022-16 Guidance on authorised representatives under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

•  Revision of MDCG 2020-10 Safety reporting in clinical investigations of medical devices under Regulation (EU) 2017/745

•  MDCG 2022-17 Position paper on "hybrid audits"

•  MDCG 2022-18 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

•  MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746

•  MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746

•  MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745

•  New expert panel opinion on general and plastic surgery and dentistry

•  Notified bodies survey on certifications and applications

•  Updated information on the applications for designation as a notified body

•  Updated information pack for candidate EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices

•  Updated version of the implementation rolling plan for Regulations (EU) 2017/745 and 2017/746

•  Update of the joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

•  European Union 2023 Chair of the Management Committee of the International Medical Device Regulators Forum (IMDRF)

Common specifications for Annex XVI products and reclassification


After the positive opinion issued by the Committee on Medical Devices, the Commission Implementing Acts on common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745, and on reclassification of groups of certain active products without an intended medical purpose (e.g. coloured contact lenses, breast implants, etc.), have been adopted and published in the Official Journal of the European Union (OJEU) on 2 December 2022.

For more, see here and here.
 

Eudamed information centre


The European Commission has set up an information centre for the European database on medical devices (Eudamed), collecting the available information to support the use of the system for all the concerned parties.

The Eudamed information centre is available here. More information can be found on the Commission’s webpage on Eudamed.

 

Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746

 

The Medical Device Coordination Group (MDCG) Borderline and Classification (B&C) subgroup has published a Manual on borderline and classification (version 2) for medical devices under Regulation (EU) 2017/745 and for in vitro diagnostic medical devices under Regulation (EU) 2017/746. The B&C also published a background note on borderline and classification for devices under the previous Directives 90/385/EEC, 93/42/EC and 98/79/EC.

 

For more, see here and here from the Commission’s webpage on Guidance.

 

Revision of MDCG 2021-22 Guidance on 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

 

The Medical Device Coordination Group (MDCG) endorsed MDCG 2021-22 Rev.1 on guidance on 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 on in vitro diagnostic medical devices.

 

For more, see here from the Commission’s webpage on Guidance.

 

New revision of MDCG 2019-6 Questions and answers on requirements relating to notified bodies

The Medical Device Coordination Group (MDCG) endorsed MDCG 2019-6 Rev. 4 about questions and answers on requirements relating to notified bodies. This revision concerns in particular question III.6 on the meaning of the term “employed” in Articles 36(1) MDR and 32(1) IVDR.

For more, see here from the Commission’s webpage on Guidance.  

Revision of 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

The Medical Device Coordination Group (MDCG) endorsed MDCG 2022-4 Rev. 1 on guidance on appropriate surveillance regarding the transitional provisions under Article 120 of Regulation (EU) 2017/745 on medical devices (IVDR) with regard to devices covered by certificates according to the previous Directives 90/385/EEC (AIMDD) or 93/42/EEC (MDD).

For more, see here from the Commission’s webpage on Guidance.

 

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

The Medical Device Coordination Group (MDCG) endorsed MDCG 2022-15 on guidance on appropriate surveillance regarding the transitional provisions under Article 110 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) with regard to devices covered by certificates according to the previous Directive 98/79/EC (IVDD).

For more, see here from the Commission’s webpage on Guidance.

MDCG 2022-16 Guidance on authorised representatives under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

The Medical Device Coordination Group (MDCG) endorsed MDCG 2022-16 on guidance on authorised representatives under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

 

For more, see here from the Commission’s webpage on Guidance.

Revision of MDCG 2020-10 Safety reporting in clinical investigations of medical devices under Regulation (EU) 2017/745

The Medical Device Coordination Group (MDCG) endorsed MDCG 2020-10/1 Rev. 1 on safety reporting in clinical investigations of medical devices under Regulation (EU) 2017/745, and the Appendix MDCG 2020-10/2 Rev. 1 with the clinical investigation summary safety report form.

 

For more information, see here and here respectively from the Commission’s webpage on Guidance.

MDCG 2022-17 Position paper on "hybrid audits"

The Medical Device Coordination Group (MDCG) adopted MDCG 2022-17 Position paper on the possible use of “hybrid audits” by notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).


For more, see here from the Commission’s webpage on Guidance.

 

MDCG 2022-18 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

The Medical Device Coordination Group (MDCG) adopted MDCG 2022-18 Position paper on the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) to legacy devices for which a certificate issued under the previous Directives AIMDD or MDD expires before the issuance of a MDR certificate.


For more, see here from the Commission’s webpage on Guidance.

 

MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746

The Medical Device Coordination Group (MDCG) adopted MDCG 2022-19 on the documents for the application/notification of performance study under Regulation (EU) 2017/746 on in vitro diagnostic medical devices.


For more, see here from the Commission’s webpage on Guidance.

 

MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746

The Medical Device Coordination Group (MDCG) adopted MDCG 2022-20 on substantial modification of performance study under Regulation (EU) 2017/746 on in vitro diagnostic medical devices.


For more, see here from the Commission’s webpage on Guidance.

 

MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745

The Medical Device Coordination Group (MDCG) adopted MDCG 2022-21 on the Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 on medical devices.


For more, see here from the Commission’s webpage on Guidance.

 

New expert panel opinion on general and plastic surgery and dentistry

The thematic expert panel on general and plastic surgery and dentistry provided the Opinion NB 2797 - CECP-2022-000227 under the Clinical Evaluation Consultation Procedure (CECP) according to Article 54 of Regulation (EU) 2017/745 on medical devices.


For more, see here from the Commission’s webpage on Expert Panels.

Notified bodies survey on certifications and applications

The European Commission published the results of a survey carried out among notified bodies for Regulations (EU) 2017/745 and 2017/746 concerning certifications of devices and applications.


For more, see here from the Commission’s webpage on Notified Bodies.

Updated information on the applications for designation as a notified body

The European Commission published updated information on the applications for designation as a notified body for Regulations (EU) 2017/745 and 2017/746 via an overview at each stage of the process.


For more, see here from the Commission’s webpage on Notified Bodies.

Updated information pack for candidate EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices

The European Commission published an updated version of the information pack for candidate EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices.


For more, see here from the Commission’s webpage on EU Reference Laboratories.

Updated version of the implementation rolling plan for Regulations (EU) 2017/745 and 2017/746

The European Commission published the latest version, updated in October 2022, of the implementation rolling plan for Regulations (EU) 2017/745 and 2017/746.


For more, see here from the Commission’s webpage on the New Regulations.

Update of the joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

The European Commission published the October 2022 update of the joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).


For more, see here from the Commission’s webpage on In Vitro Diagnostics.

European Union 2023 Chair of the Management Committee of the International Medical Device Regulators Forum (IMDRF)

Within the international cooperation activities in the field of medical devices, the European Union is going to assume the 2023 Chair of the Management Committee of the International Medical Device Regulators Forum (IMDRF).

 

For more, see here from the Commission’s webpage on International Cooperation.

Stay tuned for future updates!

To stay up to date on all information related to medical devices and in vitro medical devices, please visit the Medical Devices sections on the Commission’s Public Health website regularly.

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