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.
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