The Medical Device Coordination Group regularly publishes guidance documents to make life a little easier for economic operators. At the very least, the MDCG documents give an idea of how the EU envisions the implementation of the numerous MDR-requirements.
Although the documents are not legally binding, they represent a common understanding of how the MDR should be applied in practice to achieve effective and harmonised implementation of the legislation. Notified bodies and authorities also use these MDCG documents as a basis for assessing manufacturer documentation for review.
The following document has recently been published:
- MDCG 2022- 18 ADD.1 (June 2023)
This addition to the position paper addresses the application of Article 97 MDR to end-of-life devices. It concerns manufacturers who have been or will be requested by their competent authority to carry out the relevant conformity assessment procedure after 20 March 2023. In these cases, the expired certificate is not considered valid and the extended transition period does not apply. The MDCG considers that the application of Article 97 MDR under MDCG 2022-18 to situations where an MDD/AIMDD certificate has expired prior to the issue of an MDR certificate has served its purpose and is no longer relevant, or that its application should be limited to very exceptional situations.
We use these guidance documents as part of our support to our customers in meeting the regulatory requirements under the MDR. If you have any questions or need assistance, please do not hesitate to contact us..
(No ratings yet)
Loading...
