Safety improvements and transparency on medical devices in EU coming closer!

Today marks the midway point of the 3-year transition of the European Medical Device legislation, known as the EU-MDR. The provisions of the new legal framework are written in much clearer and demanding language than the current MDD system. More in depth review will be initiated by streamlined and harmonized notified bodies; real-world data will be required in post market review of products that have been placed on the market, and extra clinical scrutiny by a central EU Commission Expert group will be in place for long term implants.

Today is also the ‘go-live’ date of the publications on ‘the Implant File’, a collection of documents collated and researched by a group of investigative journalists from around the world, which focus on adverse events and patient stories. Although manufacturers design and market products with the aim of improving patients’ circumstances, devices sometimes fail, causing risk to the patient. Today’s market entry in Europe for example is based on notified bodies approving the risk-benefit ratio. The industry is cognizant that safety remains at the forefront of the manufacturing process.
Legislators and stakeholders have seen that improvements can be made. Where MDD several decades ago was stepping up the requirements posed in some of the EU countries to a more centralized system, it is time to learn from these years, and improve the legislation. In 18 months the transition period will end, and the new legislation will be implemented.  It will retain the best of the current system, and improve on essential elements of clinical support, safety validations, and traceability in the event of product issues.  Also, worth noting will be transparency for all stakeholders   including patients with more detailed patient leaflets, implant cards, and data on manufacturers’ websites in the central European Database EUDAMED.

With regards to clinical validation, all products will have to be evaluated, including existing products on the market.  This will result in a new ratio, where residual risks will be balanced against the demonstrated (clinical) performance. Long term implants, for example, will need to have their own clinical data, and it will no longer be possible to piggy back on data from competitors. Competitor’s products will be monitored more closely to verify if new risks for the type of product will emerge from extended use of the implants. Certain implants that have long been on the market may require a detailed clinical review, based on a list of exemptions mandated in the MDR by the legislator.
Safety validations will focus more on details of products that may leach out of medical devices, such as tubes used to administer fluids and medication. Stricter requirements will affect products made of substances that can be easily absorbed in body orifices and on the skin. Higher risk substance-based medical devices will need an additional review by a drug agency, supporting the notified body in its CE marking decision.

Traceability will be enhanced using barcoding, utilizing a system called UDI (Unique Device Identification). This will allow for thorough follow up when users and surgeons need to be notified on the safety issues that emerge over the lifetime of a device. It will also support more precise return of devices that need to be recalled. The UDI system serves as the backbone in the European medical device database EUDAMED, which stores information on product approval (CE-certification), clinical trials to support the safety and performance of the product, market surveillance reports, and all data on adverse event reporting, vigilance and recalls.

Labeling will be further enhances to include more details on risks, with cleared claims of medical performance. For implants detailed implant cards will be provided to the patients, with links to more information on the manufacturer’s website.
Just a few of the many, many changes the new EU-MDR will bring. And as there is no grandfathering, meaning all products will have to be evaluated as if they are new to the market, it will lead to a cleaning house in available medical devices with CE mark. Less variants might be available, but the ones that will remain on the market, as well as the new products entering the market will have more clearly validated demonstrated evidence of safety and performance. However, life is about accepting risks; with all the improvements made to the system, there always is a balance between risk and benefit. The risks will be further reduced, and benefits more clearly demonstrated, making the medical device world a safer and more transparent one!


Gert W. Bos, PhD, Fraps
Post date: November 26, 2018
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