Guidance on periodic safety update report according to MDR published
The published MDCG-2022-21 guiadance aims at assisting manufacturers in implementing the legal requirements laid down in Article 86 MDR and involving post market surveillance of medical devices.
MDCG published performance study application/ notification documents under IVDR
The manual records the agreements reached by the Member State members of the Borderline and Classification Working Group following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Manual on borderline and classification for medical devices under MDR and IVDR published
The manual records the agreements reached by the Member State members of the Borderline and Classification Working Group following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
MDCG publishes position paper on the application of Article 97 MDR to legacy devices
MDCG publishes 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 revises guidance document on safety reporting in clinical investigations
In October 2022, the Medical Device Coordination Group (MDCG) published a revised version of the MDCG 2020-10/1 adopted in May 2020.
IMDRF publishes guidance documents on personalized medical devices for comment
IMDRF issued guidance documents on personalized medical devices for public comment.
MDCG updates joint implementation plan for IVDR
The “Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)” is the result of review by the Medical Device Coordination Group (MDCG).
SCC Team at MEDICA-COMPAMED 2022
Thank you for visiting our booth at MEDICA-COMPAMED 2022
Release of a new MDCG document
In October 2022, the Medical Device Coordination Group has published the MDCG 2022-16 document “Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)”.
Best practice guidance for the submission of technical documentation under Annex II and III of the MDR
The best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the expectations of technical documentation submissions from manufacturers.
