MDD extension rules
 2023/03/28 | View:276

The Parliament and Council of the European Union on March 20, 2023 officially issued new regulations, the most important element, is the extension of the validity of 

the MDD CE certificate subject to the following specific conditions:


Class III devices and Class IIb non-exemption implants until the end of 2027.

Class IIb exemption implants (sutures, anastomoses, crowns, etc.) and Class IIa/I, to the end of 2028.


The extension is divided into two cases:


01 The manufacturer's MDD CE certificate has expired by March 20, 2023:

1) must have signed a certification contract with the notified body of the MDR, can not just submit an application for certification. products in the MDR certification 

contract, can be included in the confirmation letter issued by our company.


2) The device must continuously meet the requirements of MDD; the device must not have significant changes; the device must not have unacceptable risks; the 

manufacturer needs to establish a quality management system in accordance with MDR before May 26, 2024; there is still an annual audit by the notified body,

regardless of whether it is under the old regulations or new regulations.


02 The manufacturer's MDD CE certificate will not expire until after March 20, 2023 when:

1) The company commits to submit an application for certification to the Notified Body by May 26, 2024, and to sign a certification contract with the Notified Body 

for MDR by September 26, 2024. The products to be included in the MDR certification contract can be included in the confirmation letter issued by our company.


2) The device must continue to meet the requirements of the MDD; the device must not have significant changes; the device must not have unacceptable risks; 

the manufacturer needs to establish a quality management system in accordance with the MDR by May 26, 2024; there are still annual audits conducted by the 

notified body, regardless of whether under the old regulations or new regulations.


The following is a link to the original regulation:

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32023R0607&from=EN


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