Healthcare Regulatory Requirements for the UK & EU

The UK and Europe have one of the largest global healthcare markets, accounting for the second largest global healthcare expenditure compared to the US. Germany spent 11.9% of it’s GDP on healthcare in 2019, compared to 17.7% in the US. However, unlike the US, the European market is significantly more challenging to both enter and to reach patients.

The authorisation and monitorisation of pharmaceuticals, medical devices and medical technology in Europe is provided by the European Medicines Agency (EMA), which occurs through a single marketing authorisation application. The EMA is composed of several committees, which act to provide scientific guidelines and regulatory support for pharmaceutical and biotech companies during marketing authorisation application processing. They also provide scientific advice to R&D companies and contribute to the regulatory requirements processing both in the EU and internationally. The EMA’s Committee for Medicinal Products for Human Use (CHMP) carries out a scientific assessment of these applications,  before providing a recommendation on whether the medicine or technology should be marketed at that time.  The European Commission then offers a legally binding decision based on the EMA’s recommendation, which occurs within 67 days. Once this approval has been granted by the European Commission, this marketing authorisation is then automatically valid across all EU Member States and in the European Economic Area (EEA) countries of Norway, Liechtenstein and Iceland.

In the UK, regulation of medicines and medical devices is carried out by the Medicines and Healthcare products Regulatory Agency (MHRA), an executive UK agency sponsored by the Department of Health and Social Care. As of January 2021, new guidance was published by the MHRA following withdrawal of the UK from the European Union in January 2020. The new guidance outlines changes in regulations involving clinical trials, medical devices, importing & exporting, IT systems, legislation, pharmacovigilance and paediatrics. The MHRA also delivers the Yellow Card Scheme, a patient and physician targeted scheme, which is responsible for both collecting and monitoring information on safety, such as suspected side effects or adverse incidents involving medicines and medical devices. The UK National Institute for Health and Care Excellence (NICE), a non-departmental public body, also provides national guidance on improving both healthcare and clinical outcome. Emerging industries can directly engage with NICE during health technology development through targeted services. These include HealthTech Connect, which connects medical devices, diagnostics and digital health technologies to the NHS, and UK Pharma Scan, a database of information on new medicines, indications, and formulations in the UK pharmaceutical pipeline.

For medical device regulations in Europe, the Medical Devices Directive (MDD) has recently been replaced by The Medical Devices Regulation (Regulation EU 2017/745), alongside the In-Vitro Diagnostics Devices Regulation (Regulation EU 2017/746), which was commenced as of 26th May 2021. Furthermore, all medical devices including in vitro diagnostic medical devices (IVDs) entering the UK market need to be registered with the MHRA as of 1st January 2021. All medical devices entering the European market also need to be CE marked, and those entering the UK require additional UKCA marking by the MHRA.

Written by:
Anna Cranston

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