Devices Regulations in Europe

On Tuesday, I attended a Pittsburgh Technology Council event downtown titled “Medical Devices and the European Union: What does the Path of Entry Look Like?” which was sponsored by RQS! (We gave out stress balls in the shape of a pill!) I’ve posted a few times before regarding some of the regulatory hurdles of entering the US market, so I was very excited to get more perspective on the European path and share that information with all of you.

Paul Brooks, BSI’s Senior Vice President, kicked off the morning with a very passionate talk on why he thinks the EU system works so well. Compared to the US, he noted that there is more predictability to CE marking and this allows companies to make earlier returns on their investments. This is the exact reason why many companies first market their product in the EU before filing an application with the FDA. Additionally, in the EU manufacturers have the authority to apply the CE mark to medical devices as long as they prepare technical documentation and declare conformity to applicable directives and standards.

The pre-market requirements in the EU are intentionally less rigorous than the PMA or 510(k) routes. However, Brooks noted that this can only be achieved because the EU expects more on the post-market side. Post-market activities should include more than just complaint reporting and reacting to adverse events. Post-market activities should also include proactive efforts by the manufacturers such as post-market clinical follow up (PMCF), reviewing media reports, and more. This should feed back into the quality system in order to strengthen the safety and effectiveness profile of the product. Brooks said that the EU must be confident that products are safe for patients. For the pre-market bar to be set low, the post-market bar must be set high. If the EU is not confident about the post-market data they collect, they may have to raise the bar on the pre-market side.

Recently, there has been a lot of criticism of the EU’s regulatory system, mainly spurred on by a few cases: the PIP Breast Implant scandal and metal on metal hip implant problems. Many people found themselves asking if the EU’s seemingly “easier” regulatory system was putting the public health at risk. Who is accountable when things go wrong? There are quite a few players in the game - Notified bodies, authorized representatives, competent authorities, the European Commission, the manufacturers – but ultimately it is the manufacturer who is responsible for following the regulations and dealing with any recalls.

During the panel discussion of the PTC event, the one piece of advice that was echoed by all the panelists was that proper selection of notified bodies is very important. You want to know that they are able to help you down the right path and identify any gaps that you may have, before those gaps turn into huge disasters.

I really enjoyed attending this event. It was a great way to collaborate with other consultants, engineers, clinical experts, and lawyers in the Pittsburgh community.

- Sherri