As the implementation dates for the new European Regulations near, there are concerns in the industry about the resulting fairness of competition.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has written to the Directorate General for Health (DG Santé) to ensure the issues are heard at the highest level.
In its letter, EUCOPE says:
“As of today (31 January 2020) only nine Notified Bodies have received the official designation from the European Commission to operate under the Medical Devices Regulation (MD), while only three have received it for the In Vitro Diagnostics Medical Devices Regulation (IVDR). These scarcely low numbers are a cause of great concern for our members and for the sector in general…
“We have already heard of cases in some Member States where Notified Bodies are refusing to take in requests from new clients.
“We are worried the situation leads to unfair competition for smaller companies, endangering the sustainability of the system and generating delays in innovation, eventually impacting the safety of patients.“
The MDR comes into force on 26th May 2020, and the IVDR comes into force 26th May 2022.