EU MDR regulations are about to take effect, 80% of Chinese companies may be forced to give up CE certificates

It won’t be long until the end of the MDR transition period. How many Chinese companies are ready?

On May 5, 2017, the European Union officially released the new version of the Medical Device Regulation MDR (EU 2017/745). The transition period for the regulation is 3 years and it will be enforced on May 26, 2020. However, on April 24, 2020, the European Union announced that the enforcement date of the Medical Device Regulation (MDR) will be postponed by one year and will be officially implemented on May 26, 2021.

It is reported that the Medical Device Regulation ( MDR) is a document of more than 550 pages. Compared with the previous Medical Device Directive (MDD), some core concepts in the MDR remain unchanged, and many new requirements are introduced, which concretizes the requirements of the MDD.

The new EU Medical Device Regulation (MDR) not only expands the scope of application, but also refines the classification of medical devices, improves the general safety and performance requirements of medical devices, strengthens the requirements for technical documents and post-market supervision of devices, establishes a central electronic database (called Eudamed), proposes the traceability of devices, and puts forward stricter requirements for NBs.

In general, MDR focuses more on clinical performance, better traceability of medical devices, and transparency to patients. In other words, in the future, the EU will impose stricter restrictions on medical devices entering the European market and also place higher requirements on practitioners.

Compared with the European Representative under the MDD, the requirements for European Representative under the MDR are more stringent and the responsibilities are greater. In addition to bearing their original obligations, they will also bear joint and several legal liability for defective devices like the manufacturer.

After the implementation of MDR, you can still apply for a CE certificate in accordance with MDD and AIMDD and maintain the validity of the certificate during the three-year transition period. According to regulations, the CE certificate issued by NB during the transition period will continue to be valid, but the validity period will not exceed 5 years from its delivery date and will expire on May 27, 2024.

This regulation has brought a lot of trouble to Chinese exporters, including increased costs, longer certification cycles, and increased compliance risks . Affected by MDR, the industry association in Tuttlingen, Germany, estimates that 100 to 200 small companies in the area will face bankruptcy or transfer.

Others predict that if the MDR is strictly enforced , 30% of European medical companies will face bankruptcy and 80% of Chinese companies will be forced to give up their CE certificates.

For companies that have already obtained CE certificates, the top priority is to reconfirm the product risk classification level and confirm whether there is any risk level upgrade.

In addition, the seller must also confirm whether the issuing agency of the original CE certificate has obtained the MDR certificate issuance qualification approved by the EU authorities , whether the technical documents contain a clinical evaluation report provided in accordance with the Rev4 guidelines , and whether the company's compliance officer ( MDR regulatory requirements) has the corresponding ability, qualifications and experience to assume the corresponding regulatory work responsibilities.

Next, the seller needs to modify the original CE technical documents, establish a quality management system, apply for MDR-CE certification to a certification body with MDR certification qualifications, and obtain a new CE certificate under the MDR regulations.

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