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Grant Ramaley

FDA Compliance

Will New EU Medical Device Regulation Hit Tongue Depressors Before Defibrillators?

European MDR update: Lowest risk medical devices must comply by May 26, 2020

Published: Tuesday, July 2, 2019 - 12:03

Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the regulation by May 26, 2020, or be shut out of the region. 

This could be more problematic for dental products, which are inherently lower risk. Rubber dams and dental operating lights will have to comply before MRIs and pacemakers. 

To ensure that medical device manufacturers of class 1 devices understand that they must comply immediately on May 27, 2020, when the new regulation goes into effect, the European Commission states this plainly in its “Fact Sheet to Medical Device Manufacturers.”

Some regulatory professionals have been caught off guard by the EU Commission’s position on class 1 devices. Article 120—“Transitional provisions,” which provides key timeframes for implementing the regulation, gives manufacturers of higher-risk devices as much as four more years to sell their products using the older MDD. It makes little sense that higher-risk devices would be given more time to adapt than the lowest-risk medical devices, especially since other articles, such as Article 123, give more time to lower-risk device makers to comply with the unique device identification (UDI). But the EU Commission is quite clear. And the emphasis on targeting lower-risk devices doesn’t stop there.

New EU Medical Device Regulation would require that low-risk tongue depressors meet many MDD requirements before higher-risk defibrillators

Enforcement by authorized EU representatives

To further enforce compliance with the new regulation, European authorized representatives are required to obtain evidence of compliance from manufacturers of class 1 devices, by collecting copies of a new European technical file that satisfies the new requirements in Annex 1—“General safety and performance requirements.”

It is therefore expected that each manufacturer will complete and provide to its European Commission representative a completely new technical file by May 26, 2020, or risk having its contract for representation in Europe cancelled.

Notified Bodies struggling/abandoning support for Europe

Currently, there are 58 Notified Bodies supporting medical-device product certifications for the European Union. So far only 41 Notified Bodies have applied to support the new medical device regulation, six more for in vitro diagnostics (IVDs). 

To date, only two Notified Bodies have successfully met the requirements for issuing certificates under the new European MDR, and one of them is expected to lose its appointment when Brexit runs its course. 

Because CE certificates are “product certifications,” they require technical reviews by technical experts. It is estimated that 75 technical experts would be required to support any one Notified Body, given all the varieties of devices that could be certified. 

‘Self-declare’ no more

Complicating matters further are new requirements for manufacturers that were able to “self-declare” their devices as CE Mark-compliant but must now hire a Notified Body. 

It has been a concern for some time that the new IVD regulation will require that 80 percent of products, which were previously allowed to be self-declared, must be CE marked using a notified body when the new IVD regulation goes into effect. The dental industry has its own concerns with reusable surgical instruments (i.e., ones that require sterilization and reprocessing before reuse). These formally class 1 devices that were also self-declared will also require a Notified Body to certify them.

The shortage of skilled auditors and technical experts needed to support the new regulation, as well as increased demand for auditing, continues to create worry and concern for industry, and indeed the entire healthcare system. 

“In an appeal to Jyrki Katainen, the vice president of Jobs, Growth, Investment, and Competitiveness in the European Union, MedTech Europe highlighted some of the major concerns within the medical industry,” noted EU regulatory and quality consultant Advena in its newsletter. “In particular, MedTech Europe—the European trade association for the medical technologies industry—express their frustration at the fact that the industry is now ready to be assessed to the MDR; however, the regulatory system itself is not yet ready.”


About The Author

Grant Ramaley’s picture

Grant Ramaley

Grant Ramaley is the director of regulatory affairs for Aseptico Inc., a manufacturer and marketer of dental support equipment in the United States and Canada since 1975.  Ramaley also is co-chairman of the Regulatory Affairs and Standards Committee for the Dental Trade Alliance, Convener for the ISO 13485 Medical Device Working Group at the International Accreditation Forum, and Technical Committee Advisor to the Global Harmonization Working Party.