The Medical Device Coordination Group (MDCG) regularly publishes guidance documents to help make life a little more convenient for economic operators. At the very least, the MDCG documents give an idea of how the EU intends to implement 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 documents have recently been published, some of which have a direct impact on our regulatory practice:
- Mai 2023: 2023/C 163/06 “Commission Guidance on the content and structure of the summary of the clinical investigation report”
- Mai 2023: MDCG 2020-3“Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD”
- März 2023: “Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 – Extension of the MDR transitional period and removal of the “sell off” periods”
- Februar 2023: MDCG 2020-16 “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746”
- Februar 2023: MDCG 2023-3“Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices”
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..
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