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EU: Commission publishes proposal regarding the postponement of the MDR

The EU Commission has issued a press statement and the corresponding text relating to its proposal for a postponement of the MDR. The proposal must still be accepted by the EU Parliament and the Council in an accelerated process.

In a press conference and an announcement, the EU has announced that it is working on a proposal to postpone the date of application of Regulation (EU) 2017/745 (MDR) by a year.

The EU has used implementing decisions to update the lists of harmonised standards relating to Directives 93/42/EEC (medical devices), 90/385/EEC (active implants) and 98/79/EC (in-vitro diagnostics).

EU: Additional notified body for the MDR

Another notified body for Regulation (EU) 2017/745 (MDR) has been entered into the Nando database – the Hungarian organisation CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. This brings the total number of notified bodies for the MDR to twelve.

EU: Two new guidance documents published

The MDCG has published two new guidance documents. MDCG 2020-1 deals with clinical evaluation and performance evaluation for software in particular. MDCG 2020-2 contains information about medical devices in Class I, which are subject to the amended transitional provisions of Article 120 (3/4).

The MDCG has updated two of its guidance documents: Version 3 of MDCG 2018-1 on the basic UDI ID is now available; version 2 of MDCG 2019-8 on implant cards is now available.

The MDCG has issued a new guidance document (MDCG 2020-3) relating to the question of assessing significant changes to products that have been placed in the market in accordance with the further-reaching transitional provisions in Article 120 MDR.