1 YEAR UNTIL MDR APPLICATION: How to prepare for a transition to new requirements?

As of 26 May 2020, only medical devices (all classes) in conformity with the Medical Devices Regulation - MDR (EU) 2017/745 can be placed on the market as foreseen by the Article 123 of the MDR.

However, according to the ‘’sell-off’’ provision (Art.120.4),  devices - compliant with MD and AIMD directives -  placed on the market before 26 May 2020 can be made available until 27 May 2025.

After 27 May 2025,  all class devices that are still within the supply chain and that have not reached their final user as being ready for use, for example in a hospital, are no longer marketable and must be withdrawn.

It is crucial for the manufacturer to prove that products designed and manufactured according to the MD directive have been legally placed on the market before 26 May 2020 – even if not yet physically presented on the market (not yet made available on the market).

On this aspect,, as defined in the ‘Blue Guide’ on the implementation of EU product rules:

·         ‘placing on the market’ is considered when the product is made available for the first time on the EU market. Furthermore, it requires an offer or an agreement (written or verbal) between two or more legal/natural persons for the transfer of ownership, possession or any other right concerning the manufactured product. This transfer could be for payment or free of charge and does not require the physical handover of it.

·         ‘made available‘ is interpreted when a product is supplied for distribution, consumption or use on the EU market in the course of a commercial activity, whether in return for payment or free of charge.

If you wish to receive an assessment of your case, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU legislation, will gladly answer any question you may have and assist you in safeguarding and achieving your products’ compliance.

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