The European Commission published today its proposal for the European Parliament and the Council to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) by one year. This publication comes only 9 days after the Commission announced its plans to postpone the MDR (see the InsideEULifeSciences blog post here). The European Parliament and the Council will have to approve the proposal before the MDR’s current implementation date of 26 May 2020.
The Commission’s legal basis for the postponement are Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union (“TFEU”). This gives the European Parliament and Council the authority to adopt measures that ensure the establishment and functioning of the internal market, and, in particular, set high standards of quality and safety for medicinal products and medical devices. The Commission also cites the principles of subsidiarity and proportionality, arguing that the measure will ensure a high level of protection of health for patients and users, the smooth functioning of the internal market and avoid potential market disruption:
“This Union action is necessary to achieve the objective of the proper implementation and application of [the MDR] 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 [the MDR], 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.”
The Commission confirmed that its proposal does not alter the MDR substantively and does not impose any new obligations on manufacturers or other concerned parties. InsideEULifeSciences will continue to monitor developments and publish updates as they come in.