Anyone involved in medical device development and manufacturing has undoubtedly heard of the regulatory changes happening in the EU beginning May 2020, lest they have been living under the proverbial rock. So much has been written and discussed, in fact, that it can become almost as overwhelming to keep up with as the modifications brought on by the new regulations themselves. Admittedly, we’ve devoted more space to covering the topic in our sister publication, Medical Product Outsourcing (MPO), since the regulations impact the entire industry and aren’t unique to the orthopedic space.
Still, we’ve tried to keep it top of mind in ODT as well; most recently, it was discussed in Dawn Lissy’s Best Practices column. Her contribution in this issue serves as a type of “Part 2” on the topic, which continues on the theme from the last issue. In that column, Lissy brought up many of the potential problems with the rollout of the MDR in the EU. On its own, the changeover would be substantial. But given the implications of the impending Brexit and its resulting impact on notified bodies (NB) able to serve the EU (i.e., those located in the UK will not be qualified to be an NB for MDR unless they establish a location in one of the EU member states), it could lead to disaster. Lissy also highlighted the backlog of companies trying to maintain their CE mark status for products currently in the European market, since there aren’t very many NBs qualified to the new regulation. The continuation of the discussion in this issue puts a positive spin on the topic with a look at how the regulatory changes could lead to a shift in product launch strategies, which may see medical devices introduced in the U.S. first (in contrast to the industry’s often-used tactic of an EU-first approach).
For those seeking additional information, however, one only needs to review several of the articles that ran in MPO recently. For example, in the last issue (September), Peter Rose, managing director—Europe of Maetrics, provided clarification of the modifications for certain Class I products that could impact device manufacturers previously exempt from the prior regulatory system the EU had in place.
Due to an “up-classification” of certain Class I devices, manufacturers find they require the service of an NB for perhaps the first time. This is creating confusion among these companies, some of whom are not even aware their devices have had their classification change under MDR. If your company sells Class I devices previously exempt under the Medical Device Directive (MDD) in the EU, you may want to read this article to determine if you will need to seek out an NB before the deadline (if you are still interested in selling into the EU, that is). Find the article here: http://bit.ly/odt191011.
In that same issue, MedWorld Advisors’ Florence Joffroy-Black and Dave Sheppard pose several scenarios for device manufacturers currently selling into the EU. They provide the potential positives and negatives of either recertifying all products currently sold into the sector, using the opportunity to perform “portfolio management” on current offerings, or delaying action in favor of recertifying to MDD requirements. Companies unsure of what action to take or whether they are interested in continuing to sell their full product line in the EU should review this article. It can be found here: http://bit.ly/odt191012.
Representatives from WuXi AppTec authored two articles in subsequent issues of MPO—June and July/August—which focus on testing implications associated with MDR. The June column presents a deep dive on the impact the MDR has on ISO packaging standards, specifically regarding testing and validation. It also offers a series of questions device manufacturers should be asking of testing partners who will be handling products headed to Europe. The more recent column is a less narrow look at MDR; rather, it provides insights on a variety of items companies need to keep in mind regarding device testing, their outsourcing partners, and the MDR. You can find June’s column here—http://bit.ly/odt191013—and the one from July/August here— http://bit.ly/odt191014.
Hopefully, all of this worry is for naught and the EU recognizes the disarray caused by the regulatory rollout given the timing with Brexit and the issues involving available NBs. As such, a delay in implementation would avoid the potential device shortages some are predicting will occur if the timeline isn’t altered. In fact, according to an article from Aug. 2 on the Regulatory Affairs Professionals Society website (http://bit.ly/odt191015), the U.S. has raised “serious concerns” regarding the regulatory changeover. The letter to the Word Trade Organization urges the EU delay implementation by three years.
Whether the sector takes that advice or not could significantly impact how bumpy a ride this is.
