EU MDR - Who must issue an up-to-date declaration of conformity and when?
When the EU-MDR, Medical Device Regulation , comes into force next week, your products must be placed on the market in accordance with the requirements of the EU MDR.
As the EU-MDR also brings with it new requirements for the content of product instructions for use and labelling, a large number of products cannot simply be placed on the market unchanged. It may be necessary to relabel and/or repackage your products that are still in your warehouse and provide them with new instructions for use so that they can be made available on the market in compliance with the EU MDR.
However, products that were lawfully placed on the market before 26.05.2021 in accordance with the MDD (Medical Device Directive) and have been in the distributor's warehouse since then, for example, can still be ‘sold off’ by the distributor until 26.05.2025 (EU MDR, Article 120 (4)). This only applies to products that are already in the retail chain.
In addition, manufacturers of Class I devices that are subject to a higher classification under the EU MDR and will require a notified body for their conformity assessment procedure in future can continue to place their products on the market until 26 May 2024(EU MDR, Article 120(3)).
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