What impact will the new European Medical Device Regulations have on UK medicine, asks Sarah Moore
At the end of last year, after a year of fierce lobbying by patient groups and manufacturers alike, the new European Medical Device Regulations were finally submitted to the European Parliament and Council for debate and member state approval. When implemented, these new regulations will change legislation that has remained largely untouched for over 20 years.
Ongoing, high profile, prosthetic hip and breast implant litigation has played a key role in galvanising this change. However, exactly what impact these proposed regulatory changes will have, both for patient safety and product litigation in the UK remains to be seen.
EUCOMED, the organisation which speaks for European medical device manufacturers, has warned that the new regulations will stifle innovation and slow down the release of novel products into the market. For product liability lawyers, and others dealing with the after-effects of “novel” products, such as the ASR hip prosthesis, this change in pace has the potential at least to better protect product users across Europe. However, the extent to which
