The Second corrigendum (available under: Second Corrigendum) is a reaction to the increasingly critical situation regarding Class I medical devices, which are classified higher under MDR. The products concerned are in particular products of the new Class Ir (reusable surgical instruments), certain material medical devices, certain devices containing nanomaterials and regularly medical software. In future, these products will require a notified body, without manufacturers having been able to benefit from the so-called grace period in Art. 120 para. 3 MDR for “old certificates”. In view of the (still foreseeable) insufficient availability of notified bodies, it was hardly possible for manufacturers of higher-classified Class I products to meet the requirements of the MDR as early as its date of application on 26 May 2020. The Second Corrigendum helps the manufacturers of these device categories with a kind of legislative emergency operation: The grace period for old certificates will be extended accordingly to the higher classified Class I products under the MDR. The Second Corrigendum contains another merely technical consequential change in the sales period relevant for dealers (Art. 120 para. 4 MDR) for “old products”.
For the mass of Class I manufacturers who are not affected by a higher classification, but who are burdened with the stricter requirements of the MDR, the situation remains the same: product compliance with the MDR must be achieved by 26 May 2020 at the latest.
This is important for manufacturers of higher-classified products:
- An EU declaration of conformity in accordance with Directive 93/42/EEC must have been issued for the respective device before 26 May 2020. Only then the medical device can still be placed on the market under the requirements of the previous Medical Devices Directive, at the latest by 26 May 2024.
- However, all restrictions according to Art. 120 para. 3 MDR apply, which otherwise apply to products with “old certificates”. The products must continue to comply with the requirements of the Directive 93/42/EEC. In particular, no significant changes in design and intended use are possible. The products are therefore frozen in terms of innovation as long as the manufacturer wants to benefit from the grace period.
- The requirements for post-market surveillance, vigilance, registration of economic operators and devices will also be based on the MDR for these products from 26 May 2020.
It is therefore not true that the MDR has been “postponed” by 4 years for higher classified Class I products. The requirements for manufacturers regarding these aspects remain strict. They are merely given more time to cope with the capacities of notified bodies, which will probably be significantly lower in the long term. As of 09.01.2020 only nine notified bodies have been listed under MDR (list of notified bodies):
- BSI Assurance UK Ltd.
- BSI Group The Netherlands B.V.
- DARE!! Services B.V.
- DEKRA Certification B.V.
- DEKRA Certification GmbH
- IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
- MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH
- TÜV Rheinland LGA Products GmbH
- TÜV SÜD Product Service GmbH Zertifizierstellen
Do you have questions about this news or do you want to discuss the news with the author? Please contact: Dr. Florian Niermeier