The Medical Device Coordination Group (MDCG) regularly publishes very helpful documents that help notified bodies, authorities and manufacturers to correctly interpret the requirements of the MDR .
In February 2022, the MDCG 2022-4 .
This is a guideline for monitoring the transitional provisions under Article 120 of the MDR. It concerns products in relation to devices affected by transitional provisions from MDD (Medical Device Directive) to MDR (Medical Device Regulation). The guideline describes in detail how to deal with "legacy" devices in terms of market surveillance, safety reports and audits umzugehen ist.
Affected devices can be placed on the market or put into service until 26 May 2024 if they have valid certificates in accordance with the MDD , provided they continue to comply with the MDD and there are no significant changes to the design and intended purpose.
Therefore, the approved quality management system must also be maintained. However, all relevant requirements of Chapter VII of the MDR on post-market surveillance, market surveillance, vigilance and registration of economic operators and devices also (!) apply.
These special MDR-Requirements also replace the old MDD requirements for "old" MDD-Products. Until the European database for Medical Devices (EUDAMED) is fully operational, manufacturers or their authorised representatives are expected to apply the respective national provisions and take into account the MDCG 2021-1 Rev. 18 (Guideline for harmonised administrative practices and alternative technical solutions until EUDAMED is fully operational).
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