Two important pieces of medicines and medical devices regulation are currently pending in the UK and the European Union: in the UK, the Medicines and Medical Devices Bill (the UK Bill), and in the EU, the Medical Devices Regulation (the EU Regulation on Medical Devices). COVID-19 has also had an impact, with the EU Regulation on Medical Devices, which was due to start to apply to medical devices on 26 May 2020, having its date of application postponed by the EU for one year, until 26 May 2021, so as to avoid any extra burden on manufacturers during the current pandemic.
The UK Bill
The UK is currently in a transition period following Brexit, which ends on 31 December 2020. During this period medicines and medical device regulation will remain aligned with the EU. However, following the transition period, the UK will not be able to update its regulatory schemes for medicines and medical devices – as it currently relies on legislation such as the European Communities Act 1972 for amendments. The UK Bill therefore delegates powers to update the existing regulatory frameworks across three areas: human medicines, veterinary medicines and medical devices.
The UK Bill was introduced into the UK House of Commons on 13 February 2020 and, although it was passed at second reading on 2 March 2020, further progress has been postponed in light of the Covid-19 pandemic. It is proposed that, when the Public Bill Committee reconvenes, it reports back on the UK Bill by 11 June 2020.The aims of the UK Bill are fourfold:
- Providing means to depart from EU rules and regulations in the future;
- Ensuring that the regulations can be easily amended through delegated powers without having to bring a new bill before the House of Commons ever time a revision is desired, allowing the regulations to be flexible and responsible;
- Strengthening patient safety by strengthening the Medicines and Healthcare Products Regulatory Agency (MHRA), the agency that regulates medicines and medical devices in the UK, including providing it with powers that were not available under the EU such as the registration of medical devices; and
- Striking the balance between patient safety and capturing the benefits of innovation, including through the conduct of clinical trials in the UK.
During the second reading, the UK Secretary of State for Health and Social Care, Rt Hon Matt Hancock, suggested that the new rules and regulations could include:
- Requiring a digital version of product information leaflets for human medicines;
- Removing the barriers to hub-and-spoke dispensing for smaller independent pharmacies;
- Permitting prescribing by healthcare professionals such as paramedics and midwives;
- Creating a compulsory register of medical devices in the UK; and
- Granting the MHRA power to disclose safety concerns about a medical device to the public.
The EU Regulation on Medical Devices
In April 2017, the EU Regulation on Medical Devices was adopted (Regulation 2017/745 on medical devices), which, together with Regulation (EU) 2017/746 on in vitro diagnostic medical devices, will replace the two existing directives that have been in place for over 25 years, the Medical Devices Directive and the Active Implantable Medical Devices Directive. Although the EU Regulation on Medical Devices was supposed to start to apply to medical devices later this month, its application has been postponed by one year until 26 May 2021, as adopted by the European Parliament on 17 April 2020, so as not to distract from the Covid-19 relief effort. The effective date of the in vitro diagnostic medical devices regulation (2017/746) remains 26 May 2022.
The EU Regulation on Medical Devices aims to improve the safety, transparency and traceability of the regulatory system presently in place in the EU, along with ensuring that it can quickly respond to changes in the field of medical devices.
Key changes that will be brought about by the EU Regulation on Medical Devices include the creation of a broader European database on medical devices (Eudamed), which will contain different modules on actors, Unique Device Identification (UDI) and devices, notified bodies and certificates, vigilance, clinical investigations, performance studies, and market surveillance. Under the new UDI system, a unique identifier will be assigned to and marked on devices, which will improve the traceability of devices, reduce medical errors and fight against falsified devices.