Potential postponement of the Medical Device Regulation

The implementation of the Medical Device Regulation might be postponed due to the COVID-19 pandemic.

In the College meeting of 25 March 2020, Stefan de Keersmaecker, spokesperson of the European Commission, received the question whether the implementation of the Medical Device Regulation 2017/745 will be delayed. He replied by indicating that the European Commission is working on a proposal to postpone the entry into force of the new MDR for one year.

The Commission estimates to submit the proposal early April and calls on the European Parliament and European Council to adopt the proposal quickly due the implementation date set at the end of May. This proposal has been put forth to ensure that the national authorities and the industry can fully focus on the Coronavirus crisis.

Even though the European Commission indicated that they are working on a proposal, it is not certain that the implementation of the MDR will be postponed. Postponing the MDR will bring a lot of other uncertainties and decisions to be made. For example, by delaying the implementation of the MDR, will the Medical Device Directive 93/42/EC be in force for another year? A lot of Notified Bodies stopped taking on MDD assessments. Will these Notified Bodies be taking on MDD requests again?

Another question that arises is: will the implementation of the In Vitro Diagnostic Medical Device Regulation 2017/746 also be postponed as additional time will be taken to implement the MDR? As indicated, there are a lot of uncertainties and no known answers as of yet. We are sure, however, that the European Commission will provide clarity on these matters in due time.

Our advice is to keep following your own plans to comply with the MDR. Postponing the implementation may seem like a welcome surprise, but it is far from sure and complying with the MDR is inevitable in the end.

  • CE Medical

CE Medical is the Certification Experts branch that specialises in the certification of medical devices. With over 25 years of experience and complete knowledge of the EU’s medical device classification standards, our medical consultants provide tailor-made solutions to ensure your medical device and documentation meet all mandatory directives.

  • CE Medical

CE Medical is the Certification Experts branch that specialises in the certification of medical devices. With over 25 years of experience and complete knowledge of the EU’s medical device classification standards, our medical consultants provide tailor-made solutions to ensure your medical device and documentation meet all mandatory directives.

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