I’m waiting in the lounge at the Eurostar Terminal, heading home after two days at the MedTech Summit in Brussels, reflecting on all that I heard on the draft European Medical Device and In Vitro Diagnostics Regulation (MDR). The MDR is designed to bring greater scrutiny, traceability and transparency to medical devices and in-vitro diagnostic equipment used in Europe. It includes unique device identification language similar to what is currently being enacted in the United States. My colleague, Karen Conway, will provide a compare and contrast analysis of the two regulations later in another post in the Healthcare Hub.
In some ways, the timing of the MedTech Summit was perfect, coming just a couple of weeks after we heard that an agreement had been reached on the regulation text during the ‘trilogue’ discussions (the three-way negotiation between the European Commission, Parliament and the Council). And while at the conference, we had access to the current version of the text. On the other hand, it might have been better for the presenters had they had a chance to digest the text. There were a lot of disclaimers at the meeting: “This presentation now needs updating!”
Nevertheless, we’re a big step closer to the publication and enactment into law of the MDR. Most likely, this will happen at the end of 2016 or beginning of 2017. As part of the efforts to increase traceability, the MDR will mandate the unique identification of devices and the loading and maintenance of data related to those devices in a central European database, similar to the U.S. FDA’s Global UDI Database (GUDID).
The two rules have many similarities. Much of the burden, at least initially, is on healthcare manufacturers to comply with the use, labelling, marketing, data collection and maintenance requirements of the rule. If the experience in the U.S. is any indication, I see the industry working more collaboratively than ever, sharing ideas and best practices and embracing the rule as something that needs to happen. Nearly everyone seems bought into the common goal of protecting patient safety and the integrity of the healthcare industry in Europe.
There are still many issues to be resolved. And, as is the way with many European regulations, further detail is required in many areas. These will be filled out by a series of further ‘delegated acts’ that will be issued by the European Commission over the coming months and years.
One of the areas that requires further specification is the European UDI database – known as Eudamed. There are few details as to what this will look like, and what and how manufacturers, distributers and importers will load to the database. We will keep you posted as we learn more.
It is a long, messy and complicated process devising a rule to mitigate the risk of further scandals such as what we experienced with the PIP breast implants (in which industrial vs. medical grade silicone was used). Two days of discussion about the regulation at the MedTech Summit reminded me of the quote (that will be well-known to fans of the former TV show The West Wing): “There are two things in the world you never want to let people see how you make ‘em: laws and sausages.”
Still waiting in the lounge. An hour and a half late leaving. Maybe I should consider a vote for Brexit? That will only raise a whole lot more questions about the future of the MDR.