Deadline/transition – further info!
What else happened last Friday, next to the proposed extension of the MDR Deadline for legacy products (see our Newsletter from Monday)?
The mdcg_2022-18_en, a very special guidance, was published, intended to guide in particular authorities, to help manufacturer to bridge to the MDR. This is needed since the deadline extension will most likely have a cut-off date.
The MDCG 2022-18 clarifies and tries to harmonize Article 97 on “Other non-compliance”.
What is clarified:
- A missing certificate is just a non-compliance!
- The allowance from one CA to market the products is valid for the whole EU.
- Free Sales certificates may be issued.
What is harmonized:
- Member states should apply the process and accept documents in a similar manner
- Member states agree on a standard communication
Some of the rules, in particular the limitation to one year or to SMEs, cannot be found in the MDR. In any case, it may be wise, if not existential, for companies to go this route and if indeed the device is safe and this can be demonstrated objectively, then a member states may not have a choice but to allow the marketing of the products.
MDSS has already successfully supported several clients in navigating them through these complex procedures and enabling them to market the products despite facing the expiration of the MDD certificate and not being MDR certified yet.
We are looking forward to supporting all our clients as EC REP!
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