New proposal to extend MDR and IVDR transitional period?
On 9 December, the EPSCO (Employment, Social Policy, Health and Consumer Affairs Council) announced that an extension will be proposed for the transition dates of Regulations (EU) 2017/745 and 2017/746, i.e. the Medical Device (MD) Regulation and the In-Vitro Diagnostics (IVD) Regulation, respectively.
This measure was evaluated also considering the statements of the various European health ministers who, during the EPSCO meeting on 14 June 2022, had expressed their concerns on the future availability of medical devices that are essential for the European health systems.
The Medical Device Coordination Group (MDCG) was therefore invited to propose solutions since, with the deadlines currently on force according to the Regulations (EU) 2017/745 and 2017/746 a MD and IVD shortage on the market would have to be faced, with consequent serious risks for public health.
The problems have already become known for some time: the insufficient number of notified bodies designated according to Regulation (EU) 2017/745 (36 NBs so far) and 2017/746 (7 NBs so far) does not allow the clearing of the huge workload given by the new certification requests, at least not in time for the dates of the end of availability of the MD and IVD “legacy” provided for by articles 120 and 110, respectively.
It should also be taken into account that many manufacturers, while adjusting to the legal provisions of the tow European Regulations, has not submitted any application yet, while others could not submit it at all, considering the high organisational costs.
The MDCG, following the EPSCO meeting in June, had already taken further measures, actualised in the publication of guideline MDCG 2022-14 and in the revision of guideline MDCG 2019-6.
Guideline MDCG 2022-14 has introduced some non legal measures aimed at increasing the ability of notified bodies and to ensure access to them by manufacturers, in order to obtain a better regulation transition. On the other hand, the revision of guideline MDCG 2019-6 intends to remove any obstacle for the hiring of qualified staff by NBs.
Other measures are on the way, such as the revision of the guideline on medical device sampling, on appropriate surveillance and on significant changes according to the MDR as well as of the new orientations on the practical application of clinical evidence, that will also be published.
The proposal for extended transitional periods
The following changes to the Regulations are assessed by the European Commission in the proposal No. 15520/22:
- Extension of the transitional periods as per article 120.3 of the MDR based on the device risk class, with new deadline in 2027 for high-risk devices (class III and IIb MDs) and in 2028 for class IIa and I devices whose conformity assessment procedure involves a NB.
- Extension of the validity of CE certificates released according to Directive 93/42/EEC and Directive 90/385/EEC, if required for legal or practical reasons (including access to the market of Third Countries).
- Application of the extension only to devices with acceptable health and risk profiles, that have not undergone any significant change in terms of design or intended use and whose certification process according to the MDR have already been started by manufacturers.
- Removal of the provisions on the sale as per article 120.4 of the MDR and article 110.4 of the IVDR.
- Introduction of conditions to be met to ensure that the extension is only applied to devices that present no unacceptable risk for health and safety, that have undergone no significant change in the design or intended use and for which manufacturers have already taken steps to start the certification process according to the MDR.
In early 2023, the publication of a position paper by the MDCG is expected, where the proposal are explained. In the meantime, Di Renzo Regulatory Affairs will keep monitoring the progress of the regulatory landscape, supporting MD and IVD manufacturer and other economic operators of this sector with advice and consulting.
Written By: Riccardo Del Signore
Foto di Mohamed Hassan da Pixabay
