Mask CE Certification Will Be Changed To MDR. What Do You Need To Know?

After the outbreak of the new crown, masks have become a difficult daily necessities in reality. There are also thousands of mask manufacturers in China. Many of these masks have targeted the European Union, where the epidemic is serious. The basic certification requirement of the EU market is CE certification. 。

However, we have noticed that At present, the newly completed medical masks CE Certificate in the market is basically based on the European Union Medical Device Directive MDD 93/42/EEC. 。

But there is a potential crisis.

That is CE certificates for some masks on the market

There may be more than 1 months to change the version. 。

About MDR (EU 2017/745) analysis

In May 5, 2017, the European Union issued a new version of MDR (EU 2017/745). In May 25, 2017, the MDR came into effect. The old medical device directive MDD (93/42/EEC) alternates with the new MDR (EU 2017/745) directive for a period of three years.

That is to say From May 26, 2020, the MDR directive will be enforced in the European Union. It will completely replace the old medical device directive MDD (93/42/EEC) and the old active implantable medical device directive AIMDD (90/385/EEC).

What needs to be pointed out is:

A kind of After MDR is enforced, the CE certification of the new application must be carried out in accordance with MDR.

A kind of At present, products without CE certificates must be certified according to MDR since May 27th.

A kind of The MDD certificate issued before 26 in May 2020 can still be used within the period of validity until the end of May 26, 2024.

A kind of The original MDD certificate needs to be reissued before MDR fails.

●  EU MDR directive May 26th

CE authentication of medical mask at present

What are the specific implications?

1. during the new crown outbreak, the CE approved medical masks can be said that more than 95% of them are carried out according to the old MDD instructions.

2. according to the latest EU statistics, there are 56 NB announcements authorized by the old directive MDD (93/42/EEC), while only 12 of the NB announcement bodies comply with MDR authorization. That is to say, from May 26, 2020, the selectivity of CE certification audits for medical masks decreased by 80%.

3., because of the reduction of the NB:Notified Body of EU MDR, the probability of CE certification fees for medical masks will increase considerably.

4. the new version of the MDR directive is more complex than the old MDD directive, and the certification cycle is bound to lengthen. During the epidemic, some agencies claim that the possibility of issuing certificates in a few days will be basically zero.

5. medical devices such as CE certified masks must be required to have designated EU authorized representatives (referred to as "EU generation"), which is not strictly regulated in the past MDD directive for some low-risk products. However, after the MDR directive, even the medical products sold on some electronic platform will also provide the necessary generation information.

6. the MDR system audit process and requirements are more complex and cumbersome. For example, for example, in MDR clause 15, medical device manufacturers should have at least one person in charge of regulatory compliance in their organizational structure, that is, Person responsible for regulatory compliance. The personnel should have the necessary professional knowledge in the field of medical devices, and have a series of qualification requirements (such as law, medicine, pharmacy, engineering or other related disciplines), and at least one year's professional experience related to medical device regulatory affairs or quality management system.

7. for the products that have been officially launched in the EU channel, the old MDD directive CE certificate can be maintained until May 26, 2024. But if the product is not sold in the EU market until May 26th of this year, the old MDD certificate should be re applied to the MDR version after May 26th this year.

The European Union is the direct release of Regulation, which compares with the previous Directive (Directive). The difference is that the binding force has been enhanced, and the issue has immediately become effective in the EU Member States and become a binding law. The Regulation does not need to be transformed into local laws and regulations as required by Directive to carry out its implementation.

Therefore, when applying for CE certification of medical products, the enterprises should carefully consider whether they choose the latest regulations or the old instruction scheme in the transitional stage. At the same time, they need to understand and confirm the qualification of issuing the NB institutions to ensure the continuity of products in the EU market.

Attachment: from May 26, 2020 onwards

List of 12 MDR authorized agencies

Attached: Before May 26, 2020

List of 56 MDD authorized agencies

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