Metallurgy / Chemicals / Rubber & Plastics

Thanks to the support of national policies and the increase in market demand, the sales scale of my country's medical device industry has maintained an overall growth trend in recent years, and the export volume of medical devices has increased year by year: in 2019, the total export volume reached 89.129 billion yuan, a year-on-year increase of 13.13%; 2020 The total annual export of medical equipment and machinery was 125.93 billion yuan, an increase of 41.5% year-on-year.

However, after the new version of the EU’s "Medical Device Regulations (MDR)" is implemented, all domestic medical device export companies will have radical changes!

01

The EU MDR regulations come into force today!

On May 5, 2017, the European Union officially released a new version of the medical device regulation MDR (EU 2017/745), which replaced the old medical device directive MDD (93/42/EEC). The transition period between the old and new regulations is three years.

In 2019, the General Administration of Customs organized a research and evaluation base for technical trade measures to successfully respond to the new EU MDR regulations, prompting the EU to formally announce on April 24, 2020 that it will postpone the mandatory implementation date of the Medical Device Regulations (MDR) for one year. This is China Medical device manufacturers have won valuable buffer time, but the mandatory implementation date is May 26, 2021, that is, today, the "Medical Device Regulations (MDR)" has officially landed!

02

The new version of the regulations has higher requirements for machinery companies

According to the new EU medical device regulations "Medical Device Regulations" (2017/745, MDR) and "In Vitro Diagnostic Devices Regulations" (2017/746, IVDR), the EU divides medical devices into two major categories: medical device MD and in vitro Diagnostic equipment IVD.

The implementation time of MDR regulations is May 26, 2021, and the implementation time of IVDR regulations is May 26, 2022. Therefore, for all IVD companies, there is still one year to prepare for the EU's IVDR.

It is understood that the MD of invasive medical devices after MDR will be subdivided into I, IIa, IIb, and III according to the risk level; the IVD of non-invasive in vitro diagnostic devices will be subdivided into A, B, C, and C according to the risk level from low to high. D four categories.

In general, the new EU MDR regulations pay more attention to clinical performance, better traceability of medical devices, and greater transparency to patients. The specific changes include: expansion of the scope of medical devices; new concepts and definitions of medical devices; establishment of central electronics Database (Eudamed); establish product independent product identification code (UDI); improve the general safety and performance requirements of medical devices; strengthen the requirements for technical documents; strengthen the supervision of devices after the market; improve relevant requirements for clinical evaluation; for authorization The certification body (NB) puts forward strict requirements and so on.

This means that stricter restrictions will be imposed on medical devices entering the European market, and higher requirements will be imposed on medical device-related companies.

03

80% of Chinese machinery companies may be forced to abandon the CE certificate

There is no doubt that the implementation of MDR will bring a lot of troubles to all Chinese export machinery companies, such as increased costs, extended certification cycles, and increased compliance risks.

At first glance, the CE process has not changed much, but the details are actually very large, including various aspects such as safety performance requirements, clinical expectations, labeling, specifications, post-marketing requirements, etc. Therefore, all devices will be affected to a certain extent .

It is reported that due to the influence of the MDR, the German Tuttlingen Regional Industry Association estimates that there will be about 100-200 small companies facing bankruptcy or transfer.

Some insiders predict that the strictly implemented MDR will cause 30% of European medical companies to face the risk of bankruptcy, and more than 80% of Chinese companies will be forced to abandon the CE certificate...

After the implementation of MDR, the CE certificate can still be applied for according to MDD and AIMDD during the three-year transition period and the validity of the certificate can still be maintained. According to regulations, the CE certificate issued by NB during the transition period will continue to be valid, but the validity period shall not exceed 5 from the date of delivery. Year, and expires on May 27, 2024.

Therefore, after the implementation of the MDR, the first thing for all relevant companies that have obtained the CE certificate is to quickly reconfirm the risk classification level of the product to confirm whether there is a possibility of risk level upgrade. And as soon as possible to confirm whether the original CE certificate issuing authority has been approved by the EU authorities, and whether it still has the qualifications for the issuance of the MDR certificate.

It is important to know that after MDR, ability and experience will be important indicators for review. Compared with MDD period, MDR third-party certification agencies will inevitably be much less. Therefore, companies must modify the original CE technical documents as soon as possible and re-certify those with MDR certification qualifications. The organization submits a new certification application to obtain a new CE certificate under the MDR regulations.

Undoubtedly, the implementation of the new EU MDR regulations has added more difficulties and risks to all Chinese export machinery companies, but in the face of overseas markets, I believe that no company will choose to back down. Therefore, I would like to remind all companies to strengthen the awareness of medical device quality and responsibility, and to comply with the requirements of MDR regulations to ensure compliance with products and standards.

At the same time, strengthen the contact and communication with foreign customers, clarify production standards and certification requirements, and avoid follow-up certification and price disputes.