26 May 2020, the date of entry into force of Regulation (EU) 2017/475 on Medical Devices (the MDR), it is getting closer, yet at the date of entry into force most medical devices will still be on the market thanks to a CE certificate obtained with the “old” Directive 93/42/ECC. Article 120(2) of the MDR reports what will happen to the CE certificates granted according to Directive 93/42/ECC and still valid at the date of application of MDR.
According to article 120(2) of Regulation (EU) 2017/475 on Medical Devices (the MDR), certificates issued in accordance with Directive 93/42/EEC will remain valid until 27 May 2024 at the latest. However, article 120(3) establishes specific conditions that such certificates, and the related devices, have to comply with.
In short, after 26 May 2020 it will be possible placing on the market a device CE marked according to the Directive 93/42/EEC provided that:
- All certificates necessary for the placing on the market of the device in question need to be valid, e.g. a class III device needs to have a valid QMS as well as product specific certificate;
- The manufacturer assures a continuous compliance of the device with the Directives;
- No significant changes in the design and intended purpose of the device occur; if there is a significant change in either the design or the intended purpose, art. 120(3) of MDR cannot be claimed. Qualification of a change as “significant” according to art. 120(3) of MDR shall be determined on a case by case basis by the Notified Body.
In any case, even if the “old” CE Certificate is valid, manufacturer shall comply with the following requirements of the MDR:
- Registration of economic operators and of devices (see Art. 31 MDR and Art. 29 MDR);
- Post market surveillance (PMS) (see Art. 83-86, 92 MDR including Annex III but without the PMS having to be an integral part of the QMS);
- Market surveillance (see Art. 93 – 100 MDR, but device standards to be met = Directives);
- Vigilance (see Art- 87-92 MDR).
To be noted that exceptions are possible in the case that EUDAMED is not fully functional in time (then see Art. 123 para 3 d and e MDR) and that the notified body responsible of the issue of the Directive 93/42/ECC Certificate will continue to be responsible for the appropriate surveillance of all the applicable requirements relating to the devices it has certified.
Regulatory Pharma Net offers regulatory support to the Medical Devices companies to be compliance with the requirements of the new MDR 2017/745. We are available for any clarification, do not hesitate to contact us!