On May 5, 2017, the European Union Medical Device Regulation (REGULATION (EU) 2017/745, referred to as EU MDR) was officially released and came into effect on May 26, 2017. The European Commission adopted a proposal on April 17, 2020 to postpone the implementation date of the MDR for one year, and the effective date of the MDR was postponed to May 26, 2021.

The new version of the Medical Device Regulations (MDR) and the In Vitro Diagnostic Device Regulations (IVDR) are designed to ensure the safety of all medical equipment (MD) in vitro diagnostic device (IVD) products and procedures. The implementation of the new regulations means a major challenge for the medical manufacturing industry, and relevant organizations should immediately pay attention to the changes.

A stricter upgrade based on the existing regulations. Fortunately, the new version of the Medical Device Regulations (MDR) is an upgrade based on the existing regulations and adheres to the same principles as the current directives and guidelines. However, in order to better protect patients, customers, and users, while providing a consistent and transparent industry approach, the new version of the regulations has made major changes in product development, data reporting, quality assurance, post-marketing supervision procedures, and clinical evidence. Strict requirements, which have a considerable impact on all participants in the medical device industry, including manufacturers and notified bodies.

The impact of the time point on the certificate, the manufacturer usually has or is about to apply for the CE certificate, and different time stages have different effects on the validity of the certificate. In the product certification and market circulation, the time points that need to be paid attention to (the following table) and the corresponding time points will help manufacturers to arrange personnel regulations training, vehicle certification audit activities, and plan product sales in advance.

   Time period: May 26, 2017-May 25, 2020

   Certificate validity: The certificate issued in accordance with the Medical Device Directive (MDR) is valid.

   Time period: May 26, 2020-May 26, 2024

         Certificate validity: Before the mandatory implementation of the Medical Device Directive (MDR) (May 26, 2021), the certificate issued under the MDD is valid until the expiration date or a maximum of 4 years.

   Time period: 2024-2025

          Certificate validity period: MDD devices on the market (that is, they have entered the supply chain) can continue to circulate.

   Time period: May 26, 2017-May 25, 2024

Devices that comply with the MDR regulations can be certified under the MDR and allowed to be placed on the market after certification.

   Time period: After May 26, 2024

Certificate validity: Devices placed on the market must comply with MDR regulations and be certified.

Post time: Nov-15-2021