Regulation
Navigating regulation in a post-Brexit era
It feels like a lifetime ago since the UK’s referendum on European Union (EU) membership in June 2016, with the UK exiting in January 2020. But what does that mean if you are looking to bring an innovative device to the UK market, and what steps do you need to take to ensure you are successful? Laura Friedl-Hirst dives into the essential strategies for innovators in the UK’s medical device industry.
The MedTech industry is one of Europe’s most diverse and innovative sectors. But it also operates within one of the most tightly regulated environments worldwide. Driven both by complex regulatory changes and the quest for innovation, the medical device industry landscape is changing, fast. Today, the UK proudly boasts the third largest medical device market in Europe, and the sixth largest worldwide,1
with an impressive annual
turnover of approximately $33 billion (over £26 billion) and the sector continues to experience rapid growth.2
Thanks to its single-provider,
single-payer system, the UK remains a hugely a desirable market for medical device companies; however, it’s also highly competitive. As a result, bringing medical devices to
market in the UK can be incredibly tricky. But navigating this vast, intricate terrain requires more than just innovation. Not only is the industry subject to significant scrutiny, but keeping pace with regulatory changes and ensuring ongoing compliance itself is a complex and demanding task, especially for smaller companies. Brexit has brought further complexities.
In addition, the process of designing a medical device presents its own set of challenges, including compliance with strict quality standards. Ensuring that a medical device meets rigorous clinical safety and effectiveness standards required by the NHS adds another layer of complexity. For many companies, it can seem like a lot
of hoops to jump through, which is why finding the right expertise and resources is essential. Whether it’s developing regulatory strategies, or planning for market entry, staying compliant with regulations, or navigating competition, every single step demands precision and expertise. In this dynamic environment, finding the right partner can help ensure that your entry into the UK’s medical device market is
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successful and that your business can continue to grow and thrive. In this article, we dive into the current
regulatory landscape of the UK, exploring the complexities that companies face. From the intricacies of designing medical devices to navigating certification approval and classification, along with the essential steps for accessing the NHS, we break down what’s required to assist companies on their path to success.
First stop: the UK’s current regulatory landscape Since 1 January 2021, the landscape of introducing medical devices to the market in Great Britain (England, Wales and Scotland) has undergone significant changes. Notably, a new route to market and product marking – the UKCA marking – has been introduced for manufacturers seeking to bring medical devices to market. The UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) have been a crucial requirement within the UK’s regulatory framework. The UK regulation closely aligns with and currently mirrors the requirements set
forth in the following EU Directives: 1. Medical Device Directive 93/42/EEC (MDD) 2. Active Implantable Medical Device Directive 90/385/EEC (AIMDD)
3. In Vitro Diagnostics Directive 98/97/EC (IVDD)
Since Brexit, Northern Ireland and Great Britain have separated in terms of their regulatory requirements. As of 26 May 2021, the European Union Medical Devices Regulation (Regulation 2017/745) (EU MDR) and In Vitro Diagnostic Medical Devices Regulation (Regulation 2017/746) (EU IVDR) became applicable in EU Member States and Northern Ireland. However, since these EU regulations did not come into effect during the transition period, they were not automatically incorporated into UK law. While both Great Britain and Northen Ireland
are overseen by the same regulatory authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), Northern Ireland has implemented and continues to follow EU law, whereas Great Britain currently complies with EU MDD/IVDD/AIMDD (where applicable), or MDR/IVDR and/or UK MDR with the aim to create new legislation currently being drafted.
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