In a open letter sent to the Commissioner for Health, MedTech Europe provides a damning assessment of the current regulatory position in the EU.
‘The regulatory framework is unpredictable, complex, slow and costly. The result is that medical technologies – both those already on the market and future innovations − struggle to reach European patients and health systems.’
Advena, a founding member of the European Authorised Representative Association (EAAR) supports the sentiment of this open letter, including the positive suggestions, such as:
‘Europe needs a more efficient and fit-for-purpose CE marking system, taking the best of the current framework while improving resource efficiency among manufacturers, notified bodies and authorities.’
‘Such improvements to the current system should result in reduced administrative burden and costs.’
We can only hope that the EU is open to listening and more importantly, prepared to make the necessary changes.
To read the full MedTech article please click: [MedTech Article]
To read the open Letter please click: [MedTech Open Letter]
