New European medical device regulations are due within 18 months. The new rules will update the current Medical Device Directives (MDDs) for the 21st century, and close the gaps so brutally uncovered by the PIP scandal and the metal-on-metal issues. Industry is proactively adjusting their quality systems and regulatory compliance programs while key executives are encouraging EU regulators to avoid US-style over-regulation.
These were the principle themes infusing the two-day Medtech QA/RA Global Access 2012 conference hosted by the Irish Medical Device Association (IMDA) in Galway, Ireland last week. With over 250 medical technology companies calling Ireland home, including 11 of the top 13 device firms in the world, Ireland has become Europe's center of excellence for devices. And IMDA's Medtech meeting is Ireland's flagship conference.
Much of Day One was devoted to discussions of the planned MDD revisions, with speakers from the European Commission, the European Parliament, the Irish Medicines Board (IMB), Eucomed (the Advamed of Europe), and industry. Europe encourages "responsible innovation" by relying more upon vigorous postmarket surveillance, inspections and adverse event reporting rather than any pre-approval scheme such as the FDA's 510k. Instead, the EU has only pre-market assessments and the CE mark. IMB's Ann O'Conner noted that 65% of vigilence reporting leads to product recall and removal. This state of affairs, with its regulatory burden primarily on the postmarket stage, allows for rapid inclusion of new technology, and new scientific and engineering innovation, an approach I advocated in my latest book, Get to Market Now.
The EU's new MDDs will require a number of elements that are outlined in Global Hamonization Task Force (GHTF) guidelines such as:
- Summary technical evaluation document (STED);
- Unique device identifiers; and
- Adoption of the GHTF's four risk categories for medical devices.
For readers of my client newsletter, SmarterCompliance, adoption of GHTF guidelines should come as no surprise. FDA is moving to GHTF inclusion as well, albeit a bit more slowly than Europe. Whether FDA's "slowly but surely" pace of harmonized rule adoption will inadvertently put US-based device makers at a disadvantage on the global marketplace remains to be seen. European parliamentary elections are scheduled for June 2014, so expect the new MDDs to be in place by then if not sooner.
In addition to a high-level presentation by FDA on "possible, eventual 510k updates," the rest of Day One was taken up with surveys of the state of device regulations in India, China, Russia, the Middle East and North Africa.
Day Two of the conference saw speakers delve more deeply into practical implications and challenges behind the new rules. One set of challenges will be the new clinical rules in the updated MDDs. The IMDA is hosting a two-day conference later this year to address the new EU clinical evidence rules.
I had the privilege of presenting on elements of a defensible record-keeping program for complaint handling and medical device reporting. The message I had for attendees was two-fold:
First, it is clear that complaint handling records and complaint files hold both regulatory and legal risks. Focusing only on quality system compliance can leave a firm vulnerable to disgruntled customers increasingly willing to file a lawsuit to get monetary compensation. Thus, quality auditors must also assess the content of complaint records to help minimize risk to their companies.
Second, complaints can come into a device company through more than just "official" channels. Whether a complaint is made to the saleswoman manning a conference booth or to the company vice-president speaking to a patient advocacy group, each person dealing with the public must receive some level of complaint handling training.
As with any in-person compliance speech or workshop I provide, I gave attendees handouts to help with both of these issues: an internal quality auditor checklist for reviewing complaint files and a list of complaint documentation do's and dont's.
The next IMDA Medtech conference is scheduled for 2014 just as the new EU MDDs come into force. It promises to be an exciting event, so keep an eye out for announcements.
In the meantime, consider attending some of these events where I'll be offering advice on optimizing your quality system and regulatory compliance programs:
- June 14 teleconference on defensible documents
- June 22 speech on the role of IT departments in effective regulatory compliance
- July 25 teleconference on effectively managing an FDA inspection
- July 31 workshop on 21st century supplier management and qualification