This EU document is politically important because:
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5.1In response to incidents involving flawed medical devices, such as breast implants and hip replacements, the EU revised its regulatory framework covering medical devices. Most of the provisions of the new Medical Devices Regulation (MDR)32 were due to apply from 26 May 2020 but, as the Regulation applies to all medical devices — such as masks and other equipment currently under high demand due to the coronavirus outbreak — the Commission proposed that its full application be deferred by 12 months. Article 127 of the Withdrawal Agreement applies EU law to the UK until the end of December 2020, although the MDR will still need to be applied in Northern Ireland. The delay has been approved by the European Parliament and Council.
5.2Member States may grant derogations from the normal conformity assessment procedures for specific devices when this is in the interest of public health. The Commission’s amending proposal also sought 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. This change applies with immediate effect and thus affects the UK. In practice, it means that if the UK issues a derogation and informs the Commission that it has done so, the Commission could give the derogation Union-wide effect. The same would apply to derogations granted in other EU Member States and would extend to the UK.
5.3In his Explanatory Memorandum, the Parliamentary Under-Secretary of State for Innovation (Lord Bethell) explained that the Government was finalising its plans for the end of the transition period, with the priority being patient safety and patient access to medical devices. As part of this, the Government would take into account the fact that the MDR is listed in Annex 2 of the Northern Ireland Protocol and will therefore continue to apply in Northern Ireland beyond the end of the transition period when it comes into full application.
5.4We raise no issues with the Minister but consider this to be a politically important document and so we report it to the House for information. We also draw it to the attention of the Health and Social Care Committee; the Northern Ireland Affairs Committee; and the Committee on the Future Relationship with the EU.
31 Proposal for a Regulation amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions; 7179/20, COM(20) 144; Legal base: Articles 114 and 168(4)TFEU, QMV, Ordinary Legislative Procedure; Department: Health and Social Care; Devolved Administrations: Consulted; 41171.
32 Regulation (EU) 2017/745 of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
Published: 17 June 2020