Transitional rules of Article 120 MDR
Article 120, Paragraphs (2) and (3) of the Medical Devices Regulation (EU) 2017/745 (MDR) (PDF) state that devices for which valid certificates are available that were still issued by a Notified Body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) can still be placed on the market or put into service after the MDR becomes applicable. Prerequisite for this is that the Notified Body that issued the relevant certificate in accordance with the MDD or the AIMDD continues to carry out, or is able to carry out, appropriate surveillance of all requirements for the devices it has certified. Guidance Document 2022–4 (PDF) summarises what is expected of both manufacturers and Notified Bodies with respect to “appropriate surveillance” under Article 120 MDR.
QMS requirements: MDD vs. MDR
In particular, to clarify the elements to be reviewed by Notified Bodies, the guidance document explains certain obligations of manufacturers with respect to their quality management systems.
Article 120(3) MDR requires that devices still placed on the market or put into service under MDD/AIMDD certification continue to comply with either of these Directives and do not undergo significant changes in design or intended use. Therefore, in principle, the quality management system approved in accordance with the guidelines must be maintained. However, according to the first subparagraph of Article 120(3) MDR, all applicable requirements of Chapter VII of the MDR on post-market surveillance, market surveillance, vigilance and registration of economic operators for existing products must be observed instead of the corresponding requirements in the Directives.
MDR requirements other than post-market surveillance, market surveillance, vigilance, registration of economic operators and products should in principle not apply to economic operators in relation to existing products.
This is where the guidance document proves particularly helpful to manufacturers by providing a comparative table of the quality management system requirements in the MDD and MDR, which manufacturers can use to clarify which MDD or AIMDD requirements are covered by the MDR and which are not.
Guidance for Notified Bodies and supervisory authorities
Furthermore, the document provides information on the scope of duties of Notified Bodies and supervisory authorities with regard to product surveillance of existing products during the transitional provisions, which can also be used by manufacturers to see what expectations they must reckon with regarding their existing products in the context of audits and inspections.
Recommendation for action
The Coordination Group’s guidance documents do not reflect the official position of the European Commission. Hence, the recommendations are not legally binding. Nevertheless, they are to be understood as a valuable interpretation aid for economic operators to comprehend the still new MDR and IVDR. Manufacturers should keep an eye on MDCG publications and check them in terms of relevance to their own products. Following the guidance documents and setting up products in accordance with them can significantly help to avoid “trouble” with Notified Bodies and regulatory authorities when compliance with the applicable regulations is questioned.back