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