Compliance In Focus

In an article written by Jamie Hartford and published in MDDI, indicates that new EU medical regulations are expected to be finalized this year or next.  In an earlier blog, we wrote on the pending regulations and the impact it might have on the medical device industry.

As a follow-up to a recent blog about the European Union proposing tougher regulations that are similar to FDA’s pre-market approval program in the US, and the medical device industry’s concern over the legislation, it was reported that the EU parliament panel has recently approved the pre-market approval process.

As a follow up to our blog on Monday, February 25th, an article in MassDevice indicates that medical device and European Union regulators are at a stalemate over new regulations proposed. The medical device industry supports reforming the current decentralized system by allowing a new Medical Device Coordination Group to request additional assessments. This comes in the wake of the breast implant recall that many believed revealed shortcomings in the E.U.’s regulatory environment.