Due to the current SARS-CoV-2 pandemic, the European Authority proposed in the Official Journal of the EU on 3.4.2020 (CELEX number: 52020PC0144) to postpone the date of application of the new MDR Regulation 2017/745 by 1 year.
"Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/745 concerning medical devices as regards the date of application of certain of its provisions".[1]:
RATIONALE.
1. CONTEXT OF THE PROPOSAL.
"Grounds for and objectives of the proposal".
"Regulation (EU) 2017/745 of the European Parliament and of the Council, adopted on 5 April 2017, established a new legal framework to ensure the smooth functioning of the internal market for medical devices covered by this Regulation, based on a high level of health protection for patients and users and taking into account small and medium-sized enterprises active in this sector".
"The COVID 19 outbreak and the accompanying public health crisis represent an unprecedented challenge for Member States and a heavy burden for national authorities, healthcare institutions, EU citizens and economic operators. The exceptional situation caused by the COVID 19 crisis requires significant additional resources as well as greater availability of vital medical devices*, which could not have been reasonably foreseen at the time of the adoption of Regulation (EU) 2017/745".
"This exceptional situation has serious consequences for several areas covered by Regulation (EU) 2017/745 and therefore Member States, health institutions, economic operators and the other parties concerned will most likely not be able to ensure the proper implementation and application of that Regulation, as set out in it, from 26 May 2020".
"In order to ensure the proper functioning of the internal market, a high level of protection of public health and patient safety, to establish legal certainty and to avoid potential market disturbances, it is necessary to postpone the application of certain provisions of Regulation (EU) 2017/745 for one year. At the same time, it is necessary to postpone the date on which Directives 90/385/EEC and 93/42/EEC are to be repealed. These postponements will ensure that a functioning regulatory framework for medical devices will continue to exist after 26 May 2020. In addition, the proposed amendment aims to ensure that the Commission is able, at the earliest possible stage, to adopt Union-wide derogations in exceptional cases in response to national derogations in order to effectively address any shortages of essential medical devices across the Union".
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY.
Legal basis.
"The proposal is based on Article 114 and Article 168(4)(c) of the Treaty on the Functioning of the European Union (TFEU)".
Subsidiarity.
"In accordance with the principle of subsidiarity, Union action may be taken only if the objectives pursued cannot be attained by the Member States acting alone. Union action is necessary to ensure a high level of health protection for patients and users, the proper functioning of the internal market and the avoidance of potential market disturbances. The act to be amended was adopted in full compliance with the principle of subsidiarity and any amendments must be made by means of a Commission proposal".
Proportionality.
"Given the dimension of the current outbreak of COVID-19 and the accompanying public health crisis, this Union measure is necessary to achieve the objective of proper implementation and application of Regulation (EU) 2017/745 by all parties concerned. The proposed amendment aims to ensure that the purpose of Regulation (EU) 2017/745, namely to establish a sound, transparent, predictable and sustainable regulatory framework for medical devices that ensures a high level of protection of public health and patient safety and the smooth functioning of the internal market for such devices, can be achieved'.
3. RESULTS OF THE EX-POST EVALUATION, STAKEHOLDER CONSULTATION AND IMPACT ASSESSMENT.
"This proposal is not accompanied by a separate impact assessment as this has already been carried out for Regulation (EU) 2017/745. The proposal does not change the substance of Regulation (EU) 2017/745 and does not impose any new obligations on the parties concerned. Its main purpose is to postpone the date of application of certain provisions of that Regulation by one year due to the exceptional circumstances related to the current COVID 19 outbreak".
4. IMPACT ON THE BUDGET.
"The proposal has no budgetary implications for the EU institutions".
(*2020/0060 (COD) recital (3): "Medical devices such as medical gloves, surgical masks, critical care equipment and other medical supplies play a crucial role in ensuring the health and safety of Union citizens and enabling Member States to provide patients with much-needed medical treatment in the face of the COVID 19 outbreak and the accompanying public health crisis").
WHEN WILL THE PROPOSAL BECOME LEGALLY BINDING?
2020/0060 (COD) recital (13):
"As the public health crisis associated with the COVID 19 outbreak urgently requires immediate action, this Regulation should enter into force as soon as possible -".
For further details on the intended changes, please refer to the proposed amendment.[1].
As soon as the measures[1][2] of the Member States transposing EU legal acts into national law, this information should be found under the link to the national transposition[3]
References.
- [1] Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/745 on medical devices as regards the date of application of certain of its provisions https://eur-lex.europa.eu/search.html?type=named&qid=1586160245284&name=collection:eu-law-pre-acts-com, accessed 6.4.2020.
- [2] EUROPEAN COMMISION, Brussels, 3.4.2020, COM(2020) 144 final; 2020/0060 (COD). "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions," https://ec.europa.eu/info/sites/info/files/proposal_for_a_regulation_of_the_european_parliament_and_of_the_council_amending_regulation_eu_2017_745_on_medical_devices_as_regards_the_dates_of_application_of_certain_of_its_provisions.pdf, accessed 3.04.2020.
- [3] National implementation, https://eur-lex.europa.eu/collection/n-law/mne.html, accessed 6.4.2020.
