Taken aback at Commission recast proposals, MHRA offers “proportionate” solution
This article was originally published in Clinica
Executive Summary
The European Commissionis “missing the target and not addressing the real issues” relating to the implementation of the medical device directives in its consultation on the proposed recast of the directives that was made public in May. That is the opinion of Steve Owen, head of devices policy and European and regulatory affairs at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).