At the 2017 MedCon, held at Xavier University in Cincinnati OH from May 3 to 5, the good vibe from US FDA’s efforts to accelerate product approvals was washed away by the burden that EU MDR will have on medical device and IVD companies.
MDR will officially go live at the end of May, and while companies have three years to comply, experts at the event agreed that the time to get started is now.
EU regulatory expert Gert Box from QServe outlined the key factors of MDR, and he emphasized that the “R” in MDR represents the “regulation” – thus raising the bar significantly over the current “directive.”
On top of that, Gert noted that MDR contains 10x more pages (600 to 60) than the current MDD.
Of all the demands that MDR will place on medical device companies, perhaps the greatest is the expectation that medical device companies must build “state of the art” products.
MDR requires that “you include continuous improvement into your thinking,” Gert told the MedCon attendees. This continuous improvement mindset must envelope a company’s suppliers, authorized representatives, importers and other stakeholders, as they will be part of any audit.
Phillipe Auclair, Senior Director, Regulatory Strategy and Advocacy at Abbot, followed Gert’s presentation and emphasized that MDR is partly a result of the “new influencers” that include NGO’s, payers, patient organizations, and the public.
As such, the new EUDAMED database which will serve as an information exchange for the public, in which companies must share clinical evidence and other data to demonstrate their products are safe and effective.
A product’s entire value chain must be comfortable with this greater visibility of clinical evidence. Currently, many devices have relied on competitor data to gain approval, but MDR demands that data – including post-market data - be collected for each product.
Gert and Phillipe recommended a few strategies companies should take today:
- Conduct a Global Impact Assessment – know your product portfolio and the QMS in place; and identify your suppliers’ willingness to be more forthright with data visibility;
- Break Down Silos – consistent messaging across smaller groups such as QMS, PMS, CER, RM and Complaint Handling is necessary, said Gert: “We can no longer say that QA is responsible for this part, and so on. These teams must see the big picture."
- Talk to Your Notified Body Today - to make sure they have the resources to help with the transition to the MDR certificate.
Talk to UL about our solutions that can help you conduct your global assessments, as well as technologies that can eliminate the silos within your Quality Assurance departments.