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MDR Goes Into 2nd Round

MDR deadline and its pandemic-related extended transition period from MDD (Medical Device Directive) is closing in.

A brief reminder that you should have finalised your switch to MDR (Medical Device Regulation) by May 26th, 2021.

These are the Top 5 adjustments from our current “final sprint” projects:

  1. Update of the classification according to MDR
  2. Update of the labelling (incl. instructions for use, basic UDI-DI)
  3. Update of the technical documentation: design and manufacture
  4. Development of a quality management system
  5. DIMDI/EUDAMED registration

The topics and order are not representative but show that some topics were postponed by market participants. Partly because of furlough and reduced-work arrangements and partly because of other priorities.

Which topics have you possibly pushed back and should be considered again? The Medical Device Coordination Group (MDCG) published 18 guidance documents in the past year alone, which remove many ambiguities in the interpretation of the requirements. This also includes many suggestions and templates that simplify day-to-day regulatory work or perhaps dispel doubts about the quality of your own templates.

Use the last few weeks to complete your documentation and prepare for the new duties within the PMS and PMCF. If you have any doubts or capacity bottlenecks, don’t hesitate contact us. In many cases we know a shortcut to your goal.

 

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