Important Notice for Companies with Medical Devices in the European Market.

Attention to all companies with products regulated under Directive 98/79/EC: It is crucial to be aware of the latest regulatory updates affecting the validity of certificates issued by notified bodies. Effective from July 9, 2024, the following changes will come into effect:

1️. Extension of certificate validity: Certificates issued under Directive 98/79/EC before May 25, 2017, which were still valid on May 26, 2022, will remain valid until December 31, 2027, provided they have not been withdrawn.

2️. Additional conditions: Certificates that expired before July 9, 2024, may be considered valid until December 31, 2027, if specific requirements are met, such as signing a conformity agreement with a notified body or receiving an exemption from the competent authority of a Member State.

3️. Market introduction deadlines: Depending on the product class, different deadlines for market introduction are established under the new Regulation.

It is essential for all affected companies to review their current certificates and take necessary actions to comply with the new provisions before the indicated deadlines.

For further details on how these changes may impact your company and products, we recommend consulting with your legal advisor or contacting a notified body directly.

References Regulation – EU – 2024/1860 – EN – EUR-Lex (europa.eu)