AAMI News January 2020
Navigating E.U. Regulatory Reorganization under MDR
New European Union medical device regulations come into force in early 2020.
The European Union (E.U.) is approaching its highly anticipated deadline to implement the Medical Device Regulation (MDR). As the transition period comes to an end on May 26, 2020, what should device manufacturers and standards professionals expect from the regulatory reorganization?
It is clear that the MDR will impact medical device manufacturers’ business strategies and the international standards community. However, as of mid-December, there are still loose ends pertaining to international standards harmonization and conformity assessments, as well as potential deadline extensions that make the consequences of these changes hard to predict, according to Eamonn Hoxey, director of E V Hoxey Ltd. in Gloucester, U.K., and chair of the AAMI Board of Directors.
Why was E.U. MDR introduced?
The E.U.’s MDR replaces the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive and provides a new set of regulations to improve transparency and administer the production and distribution of medical devices in the E.U. by increasing the rigor and extent of pre- and postmarket oversight
The MDR came into effect on May 25, 2017 and gives currently certified medical devices until May 26, 2020 to meet the new regulatory requirements. Compliance is mandatory for manufacturers that want to market and sell their devices in Europe. Some of the major changes include:
- Increasing the focus on safety measures and risk management. Manufacturers will be required to generate more detailed clinical data to support safety and performance claims. Incidents will have to be reported in less than 15 days, serious public health threats immediately and no later than two days, and deaths or serious deterioration of health no later than 10 days.
- Changing expectations for notified bodies. Existing notified bodies (i.e., organizations designated to assess conformity before a product is placed on the market) may not achieve designation or see changes in the scope of what they are authorized to do.
- Broadening the scope of the regulation. Under MDR, some nonmedical and cosmetic products, such as plano contact lenses or contact lenses without a corrective function, will be included in the regulation’s scope.
What is the current news on notified bodies?
The pace at which the E.U. is designating notified bodies—the entities responsible for conformity assessment of medical devices under MDR—has been slower than expected. As of late November, the European Commission (EC) has designated seven MDR notified bodies, which is far less than the 20 the Commission hoped to designate for MDR and the related In Vitro Diagnostics Regulation before the new year.
“There is an undoubted issue in the number of notified bodies that have been designated to carry out conformity assessment activities, which is putting a great deal of pressure on the system and the timeline,” said Hoxey. “What perhaps gets less attention is the scope of designation for those notified bodies that have been designated and are waiting to be designated. It is important to be aware of the approved scope of your notified body and whether this is more restricted under MDR than it was under MDD. Some manufacturers are getting a surprise when they find that they have some devices that are not in the scope of designation of their notified body.”
2020 International Standards Conference
The AAMI/FDA/BSI International Conference on Medical Device Standards and Regulations and associated meetings and symposia will be held the week of April 20, 2020 at the AAMI Center for Excellence and Westin Arlington Gateway Hotel.
This year’s conference program will focus on the health technology lifecycle and delivering better patient outcomes.
For more information, visit www.aami.org/ISC.
How will the MDR incorporate international standards?
Implementing MDR may result in a reduction of harmonized international standards to guide medical device regulations. In an October white paper, representatives from the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) Advisory Board for Healthcare Standards wrote that “restricting the scope of harmonized standards to exclusively ‘European medical device regulations’ would be counter-productive for the medical field,” and result in a duplication of standards. The groups further warned that a lack of international synchronization of standards could result in conflicting standards and barriers to trade.
To help mediate the issue, Hoxey recommended building flexibility into the “scope” statements of international standards so that they can be harmonized with the provisions of national regulations. How will the regulations affect medical device manufacturers in the E.U.?
How will the regulations affect medical device manufacturers in the E.U.?
All of the E.U.’s 500,000 medical devices will have to be recertified under the new regulation. Naturally, this will greatly affect the budgets and schedules of medical device manufacturers doing business in the E.U.
MDR implementation is expected to “increase the complexity and costs of keeping existing products on the market and introducing new ones,” according to a dour report released by ICON, a Dublin, Ireland-based contract research organization. “This transition is likely to cause hundreds, if not thousands, of products to leave the E.U. market as manufacturers decide to drop older or lower-volume products.”
The MDR’s increased emphasis on clinical evidence will likely increase the amount of time and money it takes manufacturers to achieve market approval, which may lead to delays in patients getting access to devices. Ultimately, though, the MDR should lead to an increase in patient safety, Hoxey said.
Will the whole thing be delayed?
Despite anxiety about implementing MDR, it is unlikely the entire regulation will be delayed because the timeline has been set by the European Parliament and Council. However, there have been a few notable extensions to the deadline. For example, the EC extended the European Database on Medical Devices’ “go live” date to May 26, 2022 and extended the deadline for manufacturers of some low-risk medical devices to comply with the E.U. MDR.