It is particularly noted that, due to the impact of the COVID-19 epidemic, the implementation date of the MDR has been postponed to May 27, 2021.
Compliance time explanation
1. Starting from 2021.5.26, no notified body can sign the MDD and AIMD CE certificates.
2. The MDD and AIMD CE certificates obtained before the MDR takes effect are still valid during the 5-year validity period.
3. From 2017.5.26 to 2021.5.25, you can still apply for MDD certificate, valid for 5 years, but the validity period shall not exceed 2024.5.27 (the certificates obtained following the paths in MDD Annex IV and AIMD Annex 4 will expire on 2022.5.27 at the latest).
4. However, products that have been put into the EU market before the date mentioned in the preceding article can continue to be sold and used until 2025.5.27.
5. Starting from 2024.5.27, MDD certificates can no longer be used for customs clearance and marketing of the products, but the products that have been put into the market before that date can continue to be sold and used on the client until 2025.5.27;
6. After 2020.5.26, the post-market surveillance and management activities must comply with the requirements of the MDR Directive;
7. If the products under the MDD have not been delivered before 2025.5.27, after 2025.5.27, GAME OVER. Even if they have entered the EU, as long as they have not been delivered to the hospitals, the hospitals can no longer accept them.
8. Since 2021.5.26, no notified body can sign the MDD/AIMD CE certificates, so manufacturers who continue to use the MDD/AIMD CE certificates shall ensure:
1) Any content on the CE certificate no longer changes, such as new categories and new sites.
2) There are no major changes in the design and intended use of the products already on the market, and no new models added to the same category.
In the case of any change, you must reapply for the MDR certificate.
Discussion on the compliance time for Class I devices
1) In the case that the original self-declaration mode is changed to the mode where the notified body participates in the conformity assessment under the MDR regulations, the compliance date is May 27, 2024;
2) For Class I devices that are in the self-declaration mode under both the original and new regulations, it is recommended to prepare the compliance evidence in accordance with the MDR regulations starting from May 27, 2021.