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BRUSSELS, Belgium: After a three-year transition period and a delay of 12 months owing to the SARS-CoV-2 pandemic, new regulations now apply for medical devices for human use in the European Union. The new and stricter rules mainly apply to those who manufacture, import and sell medical devices; however, dental professionals should be aware that distributors must keep a register of any complaints or reports received from health professionals and patients relating to devices and forward these complaints to the device manufacturer or importer.
Commonly referred to as the MDR (Medical Device Regulation), Council Regulation (EU) 2017/745 came into effect on 25 May 2017 with a grace period of three years. The MDR repealed Council Directive 93/42/EEC, known as the Medical Device Directive (MDD), and Council Directive 90/385/EEC, which regulated active implantable medical devices in the EU. An additional directive—Council Regulation (EU) 2017/746, known as the In Vitro Diagnostic Regulation (IVDR)—came into effect in tandem with the MDR and is set to regulate in vitro diagnostic medical devices when a five-year transition period expires in May 2022.
The European Commission, in April last year, announced a 12-month delay of the application of the MDR. A statement from the commission explained that the decision was made so that member states, health institutions and commercial operators in the medical devices industry could prioritise efforts to combat the pandemic. “Shortages or delays in getting key medical devices certified and on the market are not an option right now,” commented Margaritis Schinas, vice president for promoting our European way of life, in the media release. Indeed, the MDR is denser and more complex than its predecessor and transposing the directive has been a mammoth task for all stakeholders.
What will change under the EU’s new medical device regulations?
Compared with the repealed MDD, the MDR changes device scope and the way that medical devices are classified. For example, the legislation includes new rules for devices that use hazardous substances and for software applications. Some devices have been reclassified under the MDR, and the directive regulates certain devices that were previously exempt from medical device regulations.
The MDR also brings changes to the oversight process. Under the new directive, only notified bodies that are designated under the MDR can verify medical devices as being fit for use in the EU. Notified bodies that were designated under the MDD must be newly designated under the MDR. According to a white paper published by the Brussels-based European business law firm contrast and the Association of Dental Dealers in Europe—seen by Dental Tribune International—the public health situation in Europe has hampered efforts to designate enough notified bodies. Since some notified bodies that were designated under the MDD may not receive designation under the MDR, it is expected that some medical device manufacturers will need to change notified bodies.
The MDR also brings heightened post-market surveillance to the medical devices market
Other examples of the various changes brought by the MDR include a redefined economic operator concept, which differentiates between manufacturer, authorised representative, importer and distributor. All economic operators must conform to the directive and the responsibilities of these stakeholders are expected to increase.
The MDR also brings heightened post-market surveillance to the medical devices market, and EU member states are required to adopt penalties for any infringements of its requirements. Unique identifiers must be placed on medical devices so that they can be registered on a new European database. Named EUDAMED, the database will record the registration of devices, the accredited notified bodies, and also certificates and reports of incidents relating to the safety and clinical performance of devices.
Distributors will be required to keep a record of any complaints or reports that they receive from health professionals and immediately forward them to the manufacturer and/or importer of the device in question. Distributors of medical devices must also keep a register of non-conforming devices and devices that were recalled or withdrawn from sale.
The full text of the MDR is available here.