Machinery / Industrial Parts & Tools

Medical equipment is an internationally recognized high-tech industry and an integral part of a country's high-tech comprehensive strength. Thanks to the support of national policies and the increase in market demand, the overall sales scale of my country's medical device industry has maintained a growth trend, and the export quota of medical devices has increased year by year.

Based on the characteristics of medical device products, the technical trade measures of medical devices in various countries are relatively prominent.

It is reported that the EU will enforce the new version of the Medical Device Regulation MDR (EU 2017/745) on May 26, 2021.

Previously, on May 5, 2017, the European Union officially issued 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.

The main classification of EU medical devices under the new regulations

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.

Invasive medical devices MD are subdivided into categories I, IIa, IIb, and III according to their risk levels; non-invasive in vitro diagnostic devices IVD are subdivided into categories A, B, C, and D according to risk levels from low to high.

The main changes of the new EU medical device regulations MDR

In general, the new EU MDR regulations pay more attention to clinical performance, better traceability of medical devices and greater transparency to patients.

Specific changes include: expanding the scope of medical devices; proposing new concepts and definitions of medical devices; establishing a central electronic database (Eudamed); establishing product independent product identification codes (UDI); improving the general safety and performance requirements of medical devices; strengthening Requirements for technical documents; strengthen the supervision of medical devices after the market; improve relevant requirements for clinical evaluation; put forward strict requirements for authorized certification bodies (NB), etc.

This means that the European Union will impose stricter restrictions on medical devices entering the European market, and impose higher requirements on industry companies.

How can companies prepare for it?

The new EU MDR regulations will bring about increased costs, prolonged certification cycles, and increased compliance risks for Chinese export companies. It is recommended that relevant companies make corresponding preparations.

One is to increase the focus on the new MDR regulations and do a good job in renewing the CE certification. The CE certificate issued before the transition period is valid for no more than 5 years and will become invalid on May 27, 2024. Those who apply for CE certification after May 26, 2021 must follow the MDR regulations and be issued by an authorized NB.

The second is to establish a sense of quality and responsibility, and produce in compliance with the requirements of MDR regulations to ensure the compliance of products and standards.

The third is to strengthen communication with foreign customers, clarify production standards and certification requirements to avoid subsequent certification and price disputes.