Declaration of Conformity – Issued by Whom and When (Class I etc.)?
With the start of the sole validity of the European Medical Device Regulations (EU-MDR) in the coming week, your products must be placed on the market in compliance with the requirements of the EU-MDR.
Ensuring your declaration of conformity is up to date one step. Since the EU-MDR also brings with it new requirements for the content of the instructions for use and labelling of products, a large number of products cannot simply be placed on the market unchanged. It may be necessary to relabel and / or repackage your products, which are still in stock, and to provide them with new instructions for use so that they can be made available on the market in accordance with EU-MDR.
Products that were legally placed on the market in accordance with the MDD before May 26th, 2021 and have been in the distributor’s warehouse since then, for example, can still be “sold off” by them up to May 26th, 2025 (EU-MDR, Article 120 Paragraph 4 ). This only applies to products that are already in the retail chain.
In addition, manufacturers of Class I products that have been upgraded by the EU-MDR and will need a notified body for their conformity assessment procedure in the future can continue to place their products on the market until May 26th, 2024 (EU-MDR, Article 120 Paragraph 3).