Insights

Keeping up with the EU MDR regulatory changes

Article written by Lauren Harris, Director of X4 Life Sciences. 

The EU have recently postponed the introduction of MDR for one year to 26th May 2021 due to the coronavirus pandemic. This will replace the EU’s current Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC).

EY stated the aftermath of the shake-up will be a stronger, more accountable medtech industry that may look substantially different from today. For some companies, only a small part of their portfolios will be affected by the changes; but for others, the compliance process may be applicable to nearly all product lines. Under the new rules, medtech companies will have to:

  • Provide substantially more clinical evidence to get products to market, or even to keep some products on the market
  • Conduct deep portfolio audits to determine the new rules’ impact on margins
  • Relabel products and make data ready to be made publicly available

The delay gives companies some extra time but should not divert their attention away from MDR compliance. It’s an opportunity to close any gaps, adjust to the new timeline and ensure you have the right talent on-board.

X4 Life Science’s regulatory affairs team have been working closely with our medtech clients as they prepare to meet the new MDR regulations. Our consultants have supported building regulatory and quality teams in house as well as providing skilled MDR versed contract consultants who can either help lead the MDR project on site or support on site teams.

If you want any advice or support with assembling a team for the new MDR regulations, then don’t hesitate to reach out to me directly on LinkedIn.

 

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