Yuri Ceragioli -

The entry into force of the new regulation is now close. From 26 May 2020 it will no longer be possible to obtain a CE mark compliant with the Directive 93/42/EEC.

In any case, this does not mean that all CE certificates complying with the Directive 93/42/EEC will be canceled or that the devices currently on the market, in accordance with the Directive 93/42/EEC, will be immediately withdrawn.

Article 120 of the European Regulation 2017/745 states the clarifications you might need about this.
According to Article 120, all the CE Certificates issued by notified bodies in accordance with Directive 93/42/EEC prior to 25 May 2017 will remain valid until the end of the period indicated on the certificate, with the exception of the certificates issued in accordance with Annex IV to Directive 93/42/EEC that will become void not later than 27 May 2022.

The CE Certificates issued in compliance with Directive 93/42/EEC from 25 May 2017 will remain valid until the end of the period indicated on the certificate. However, they will become void not later than 27 May 2024.

In the cases described above, CE marked medical devices may be placed on the market or put into service, provided that from 26 May 2020 it continues to comply with the Directive, and provided that there are no significant changes in the design and intended purposes.
Additionally, all the devices placed on the market under Directive 93/42/EEC will still be available on the market or put into service until 27 May 2025.

It should be highlighted that the requirements of the European Regulation 2017/745 relating to post-markets surveillance, vigilance, registration of economic operators and devices will replace the old directives.

To sum up, this means that it will still be possible to use the CE certificates obtained with the old directive (at least for a few years) and that all the medical devices put on the market according to the directive won’t have to be withdrawn (at least till May 2025).

However, companies must in all cases comply with all the requirements of post-market surveillance, market surveillance and vigilance therefore the internal organization, the quality management system and the technical file must be updated accordingly.

Don’t be caught unprepared! RPN is at your disposal to offer you support to better manage the transition from the current directive to the new regulation.

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