Yesterday the European Parliament voted on a new approvals process for marketing medical devices (Debate (start time 8.42)). Investors can breathe a sigh of relief. There was pressure to introduce centralised EU approvals, prior to marketing, for medical devices. Many commentators thought that this would result in considerable delays in getting to market, and would have sent a chill through investment proposals for new MedTech companies. Euro MP’s rejected that pressure.
Euro MPs did vote to revise medical device regulation, and in favour of the current Commission proposals (Communication, and Medical Devices proposal and In Vitro Diagnostic proposal). The result, details of which still require to be settled between Member States of the EU, will be significantly tighter regulation. This will cost more to undertake -- including the use of common standards and approved reference laboratories. In addition there will be wider spot checks on evidence of safety. Ms Roth-Behrendt explained that this was a procedure to be introduced in the light of the recall of hip replacements. She said that it was a procedure which should only take 4 months to complete (Debate (start time 8.42)).
Implementation is likely to be no earlier than 2015. Companies would be well advised to understand the implications well before that time, as it is likely that more rigorous tests carried out by a smaller number of approved testing centres will be required.
However, the key immediate implication is that the medical device sector is still open for business, and the position has been welcomed widely (and here and here). Time to market is still likely to be significantly shorter than in the USA, and that is critical for investors and companies they are intending to support.