The Medical Device Coordination Group (MDCG) regularly publishes guidelines to make life a little easier for economic operators. At the very least, the MDCG documents give an idea of how the EU envisages 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 in order to achieve an effective and harmonised implementation of the legislation.

Notified bodies and authorities also use these MDCG documents as a basis for assessing the manufacturer documentation that is to be reviewed. New documents were published again in December 2022 and January 2023, some of which have a direct impact on our regulatory practice:

• On the distinction and classification of medical devices: “Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices …”.

• On the appropriate monitoring of MDD products: „MDCG 2022-4 rev. 1. Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates under the MDD or the AIMDD.”

• On hybrid audits: MDCG 2022-17 "MDCG position paper on hybrid audits".

• For old appliances with expiring MDD certificate: MDCG 2022-18 “MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate”.

• For application/registration of IVD performance studies: MDCG 2022-19 “Performance study application/notification documents under Regulation (EU) 2017/746”.

• To amend an IVD performance study: MDCG 2022-20 “Substantial modification of performance study under Regulation (EU) 2017/746”.

• To update a PSUR: MDCG 2022-21 „Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745“.

• About healthcare facilities: MDCG 2023-1 “Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746”

• For fees: MDCG 2023-2 "List of standard fees".

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 support, please do not hesitate to contact us..

(1 Rating(s), average: 5.00 out of 5)

Loading...