Explanatory Memorandum to COM(2020)144 - Amendment of Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions - Main contents
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| dossier | COM(2020)144 - Amendment of Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions. |
|---|---|
| source | COM(2020)144  |
| date | 03-04-2020 |
1. CONTEXT OF THE PROPOSAL
Reasons for and objectives of the proposal
Regulation (EU) 2017/745 of the European Parliament and of the Council, adopted on 5 April 2017, establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices covered by that Regulation, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector.
The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, EU citizens and economic operators. The COVID-19 crisis has created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/745.
Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745 and therefore it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as it provides for.
In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty, and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745 by one year. At the same time, it is necessary to defer the date of repeal of Directives 90/385/EEC and 93/42/EEC. Those deferrals safeguard the presence of a functioning regulatory framework on medical devices from 26 May 2020. In addition, the proposed amendment seeks to ensure that the Commission is able to adopt, in exceptional cases, Union-wide derogations in response to national derogations at the earliest date possible in order to address potential shortages Union wide of vitally important medical devices in an effective manner.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
Legal basis
The proposal is based on Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union (TFEU).
Subsidiarity
According to the principle of subsidiarity, Union action may only be taken if the envisaged aims cannot be achieved by Member States alone. Union intervention is required to ensure a high level of protection of health for patients and users, the smooth functioning of the internal market and avoid potential market disruption. In this regard, the legislation, that is being amended, is adopted in full compliance with the principle of subsidiarity and any amendment thereto must be made through a Commission proposal.
Proportionality
This Union action is necessary to achieve the objective of the proper implementation and application of Regulation (EU) 2017/745 by all involved parties, taking into account the magnitude of the current COVID-19 outbreak and the associated public health crisis. The proposed amendment aims to ensure that the intended purpose of Regulation (EU) 2017/745, that is, to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which guarantees a high level of protection of public health and patient safety and the smooth functioning of the internal market for such devices, can be attained.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
This proposal is not accompanied by a separate impact assessment, as an impact assessment for Regulation (EU) 2017/745 has already been undertaken. This proposal does not alter Regulation (EU) 2017/745 on substance and does not impose new obligations on the concerned parties. It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of that Regulation.
4. BUDGETARY IMPLICATIONS
The proposal does not have a budgetary impact for the EU institutions.