The European Parliament recently adopted a stricter, more extensive Medical Device Regulation (MDR) to replace the Medical Device Directives (MDD). It will affect all manufacturers selling devices in the European Union. What does the new regulation mean for device manufacturers? Will it make life harder and increase costs for them?
“There’s going to be some reclassification and up-classification of products,” said Linda Chatwin, manager of medical regulatory advisory services for North America at Underwriters Laboratories, popularly known as UL (1). “You will need to evaluate your products and whether they still apply under the new classification rules.”
The European Parliament adopted the MDR on April 5 to strengthen the regulation of medical devices in the European Union. It was published on May 5, which marked the beginning of a three-year transition period. The entity has also adopted a regulation for in vitro diagnostic medical devices (2).
The MDR is a 306-page document consisting of 10 chapters and16 annexes. The preamble alone covers 28 pages.
In a free webinar, Chatwin explained what the switch from MDD to the new MDR means and offered some practical tips for device manufacturers.
Here are the highlights of Chatwin’s webinar:
New Requirements for Notified Bodies: Notified Bodies need to be re-certified under the new regulation. “There will probably be fewer Notified Bodies that will be re-certified. What that means for companies is—it will be more difficult to get your assessments done. You need to work with your Notified Bodies early,” advised Chatwin.
Vigilance and Postmarket Surveillance: There are increased requirements for vigilance and postmarket surveillance under the MDR, with new requirements pertaining to unique device identification (UDI) and registration of products.
“You’re going to need a postmarket surveillance plan in place with ongoing postmarket clinical follow-ups and determine how to get that follow-up information and how to include them in your postmarket studies,” said Chatwin. Her advice: Conduct postmarket surveillance as soon as possible.
Obligations of Manufacturers: In addition to ensuring that the design and manufacture of the medical device are in accordance with the new regulation, companies also must establish, execute, maintain, and document a system for risk management.
They must conduct clinical evaluations, including postmarket clinical follow-up. They have to also prepare and update technical documentation as specified in the MDR, which allows conformity assessment by the Notified Bodies. If there are significant changes in the technical files, the Notified Bodies will look into the files at a deeper level.
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Obligations of Distributors, Authorized Representatives (AR), and Importers: Distributors and importers are now specifically regulated under the MDR. “Review your relationships with all of your distributors and importers to ensure that they are in compliance because you as a manufacturer might be liable for their actions,” said Chatwin.
Under the MDR, there are new responsibilities for authorized representatives, as well as increased liability. Spell out those responsibilities in a contract. Chatwin also suggested establishing audit procedures that will include distributors, AR, and importers.
CE Mark Validity: CE marks issued under the MDR will be valid for a maximum of five years, but void at the latest four years after the date of application for those certificates. The first CE marks under the MDR are expected to be issued by Notified Bodies in early 2019.
“If you have CE marks under different annexes, make sure you understand and know how long your CE marks are valid,” said Chatwin.
In conclusion, she advised assembling a multidisciplinary team to take charge of the switch from MDD to MDR. Forming study groups within your organization and putting project management in place to identify in detail your MDR requirements will also go a long way toward a smooth transition.
Watch Linda Chatwin’s webinar for free:
Cindy Fazzi writes about the life science industry and other regulated environments for MasterControl. She has worked as a journalist in three countries. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York City. She has a master’s degree in journalism from Ohio State University.
(1)UL LLC, a global independent health sciences company, provides support, advocacy, and expertise to medical device manufacturers.
(2) From the European Commission’s press release on April 5, 2017:
From the Official Journal of the European Union (publication of MDR), May 5, 2017: