For non-sterile medical mask products, which are Class I medical devices, the issuance of certificates by notified bodies is not applicable. The standard notified bodies will not issue any form of CE certificate for Class I devices (non-sterile, without measurement function, and non-reusable).
Brexit originated from the Brexit Referendum on June 23, 2016 and triggered Article 50 on March 29, 2017, which stipulates that the UK shall complete Brexit within 2 years. During this period, there were three postponements, and finally the time for Brexit was set to January 31, 2020. Moreover, the UK obtained a transition period ending December 31, 2020 after Brexit.
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. Starting from 2021.5.26, no notified body can sign the MDD and AIMD CE certificates.The MDD and AIMD CE certificates obtained before the MDR takes effect are still valid during the 5-year validity period.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).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.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;
IVDR compliance schedule：The effective date of IVDR is May 25, 2017;The implementation date of IVDR is May 26, 2022;Before May 26, 2022, an application can still be filed for the re-certification of the original certificate issued by the IVDD notified body, but the validity period will terminate on May 26, 2024;Starting from May 26, 2022, no CE certificate will be issued by any IVDD notified body;Starting from May 26, 2024, no IVD product holding the CE certificate issued by the IVDD notified body can enter the European market.
Unique Device Identification (UDI) is the identification given to a medical device throughout its life cycle, and is the only “identity card” in the product supply chain. The global adoption of a unified and standard UDI is conducive to improving the transparency and operational efficiency of the supply chain, to information sharing and exchange, to monitoring of adverse events and recall of defective products, and to improving the quality of medical services and ensuring the patient safety.
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