New and updated MDCG Guidance documents released!

On March 24th, 2022, the Medical Device Coordination Group (MDCG) released a revision to an existing guidance. In addition, on April 26th and May 4th the MDCG released two new documents. The previously released guidance on the summary of safety and clinical performance, a guide for manufacturers and notified bodies (MDCG 2019-9) was updated to revision 1. While the two new documents provide guidance on the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (MDCG 2022-5) and offer guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR (MDCG 2022-6).

New and updated MDCG Guidance documents released!

An updated version was released of the guidance on performance evaluation of SARS-CoV-2 IVDs. Moreover, two new documents were published to provide information regarding the verification of manufactured class D IVDs by notified bodies and to offer 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.

New MDCG Guidance documents released!

MDCG published a notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices (MDCG 2022-1) and offers guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (MDCG 2022-2).

IVDR Amending Regulation Published!

The IVDR amending regulation 2022/112 as regards transitional provisions for certain in vitro diagnostic medical devices was published!

New MDR and IVDR harmonised standards published!

Commission Implementing Decisions (EU) 2022/6 and 2022/15 as regards to harmonised standards, for MD and IVD respectively, were published in the Official Journal of the European Union (OJEU).

Progressive roll-out of IVDR adopted!

The European Parliament and Council adopted the European Commission’s proposal for a progressive roll-out of the IVDR without any changes. This amending Regulation does not change any requirements of the IVDR in substance but only changes the transitional provisions stipulated in Article 110, to allow a progressive rollout.

New MDCG Guidance documents released!

New guidance documents were released by the Medical Device Coordination Group. They provide clarification on requirements for “legacy devices”, repackaging & relabelling activities and provides guidance with regards to substantial modifications of clinical investigation under MDR.

Implementing Regulation eIFUs for Medical Devices!

December 14th, 2021, the European Commission issued the Implementing Regulation 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices.

Implementing Regulation on EUDAMED

November 26th, 2021, the European Commission issued the Implementing Regulation 2021/2078 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (EUDAMED).

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