MDCG guidance on application of MDR Article 5(5) to in-house medical devices published

MDCG issues the guidance on application of MDR Article 5(5) setting rules for the manufacture and use of in-house medical devices

Commission implementing regulation (EU) 2022/2346 and 2022/2347 regarding MDR published

Regulation (EU) 2022/2346 lays down common specifications for all groups of products in Annex XVI of the MDR without an intended medical purpose.

EU commission adopted proposal for a longer transition period to adapt to MDR

The transition period is extended until 31 December 2027 for higher risk devices, until 31 December 2028 for medium & lower risk devices and until 26 May 2026 for class III implantable custom-made devices.

Guidance on appropriate surveillance regarding the transitional provisions under MDR Art.120 revised

Devices with valid certificates may be placed on the market or put into service after the date of the MDR application and no later than 26 May 2024 under certain conditions.

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.