27.03.2020 // Actualités générales

Important update on the Medical Device Regulation (MDR) implementation

European Commission wants to postpone new MDR regulation and adopts harmonised standards for medical devices and protective equipment

In view of the COVID-19 crisis, the European Commission wishes to postpone the implementation of the Medical Devices Regulation (MDR) for one year. The commission is working on a proposal for the European legislators (Council and Parliament) by the beginning of April. In addition, the European Commission adopted decisions on harmonised standards to ensure, for example, the supply of medical face masks and disinfection equipment. These standards should allow for a faster and cheaper conformity assessment procedure.

The European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR):
Please find some further information in the read-out of the College meeting of 25/03/2020

The European Commission has adopted earlier this week three Implementing Decisions regarding the publication in the Official Journal of the European Union (OJEU) of harmonized standards under:

  • the Medical Devices Directive 93/42/EEC (MDD)
  • the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVD)
  • the Active Implantable Medical Devices Directive 90/385/EEC (AIMD)

These three Commission Implementing Decisions can be found on this webpage.

These Implementing Decisions contain:

  • MDD 93/42/EEC: a total of 264 standards listed (incl. 16 new/revised) and 12 standards are withdrawn
  • IVD 98/79/EC: a total of 41 standards listed (incl. 4 new/revised) and 3 standards are withdrawn
  • AIMD 90/385/EEC: a total of 46 standards listed (incl. 5 new/revised) and 4 standards are withdrawn

It is to be noted that this procedure was triggered by the urgent need to have some new/revised harmonised standards playing a critical role in the current COVID-19 crisis cited in the OJEU as soon as possible (e.g. EN 14683:2019 on medical face masks, EN 13795:2019 on surgical clothing and drapes, etc.).

Please find further information on this webpage.

European standards for medical supplies made freely available to facilitate increase of production
Please find further information on this webpage.

Influence on standardization
Standards represent an important part in fighting the current health crisis. CEN is therefore committed to continue the standardization work and collaborate with all players involved. As a member of CEN, SNV is fully supporting this commitment. However the CEN/BT Technical Board is aware of the possible effects on work in the TCs and WGs and will monitor the development and take decisions as necessary.

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