The prospect of the UK’s departure from the European single market and customs union seriously jeopardises how medical technologies are regulated in post-Brexit Europe. The big fear is divergence in the rules governing diagnostics and medical devices.
The timing is far from ideal. EU Member States have adopted new In Vitro Diagnostics (IVD) and Medical Devices (MD) Regulations. As this is a significant overhaul of the existing EU directives, authorities and companies have five years to adapt to the new rules on IVDs and three years for medical devices.
These transition periods are already looking tight and are further complicated by the regulatory uncertainty that comes with Brexit. MedTech Europe, which represents a medical technology sector dominated by more than 25,000 SMEs, has published a detailed position paper on the challenges this poses for the industry.
We also point to solutions that may mitigate the risk of disruption. By fully aligning its post-Brexit medtech regulatory system with the EU27, the UK would foster innovation, competitiveness and trade while safeguarding patients. In practice, this would mean drafting legislation that mirrors the new EU rules for diagnostics and devices.
Impact on patients
Failure to get this right poses serious risks for patients. EU regulations have allowed timely access to safe and effective technologies for 25 years. If some products become unavailable post-Brexit, or if supply is much slower than it is at present, patients will miss out on highly valuable products. For example, they may wait longer for diagnoses – with potentially worse outcomes as a result – or be unable to benefit from the latest surgical interventions. There is a lot at stake.
Loss of expertise
A related source of uncertainty arises from a lack of clarity on the future of UK Notified Bodies which grant CE marks to new medtech products and renew CE marks for existing products. At present, thanks to the quality and expertise of the UK’s Notified Bodies, a sizeable chunk of products on the market across the European continent have been certified there.
If these bodies effectively leave the European system, it would represent a sudden loss of expertise and raise questions over whether UK-issued CE marks would comply with the new EU regulations.
The solution might be for both sides to continue to recognise existing CE marking certificates issued by the UK until their expiry date. We would also like to see UK Notified Bodies remain with the European network of oversight mechanisms and continue to be allowed to assess devices for the EU27 and UK markets. This is not a radical idea – the EU and Switzerland already operate a mutually beneficial system of this kind.
Notified Bodies is not the only piece of the regulatory framework facing uncertainty. Legal entities – such as authorised representatives, legal manufacturers and importers – may no longer have a mandate from the UK to address EU27 legislations.
Here, again, the Swiss-EU model points the way. Through a Mutual Recognition Agreement, legal entities based in the UK could be recognised as EU-based legal entities, avoiding the need to relocate to the EU27 jurisdiction.
Seamless trade
Patient access to life-saving diagnostics and devices is threatened in another way: any new rules and procedures affecting customs and free movement of goods creates serious uncertainty and new costs for businesses.
Not only might it become difficult for companies to trade across the EU-UK border if the conditions are not carefully crafted, but production and supply chains could be disrupted in a manner that could set us back several decades.
Modern medtech businesses sometimes avail themselves of ‘just-in-time’ distribution – a lean approach that cuts costs by producing and delivering finished goods only when they are ready to be sold. This system would be severely strained if customs controls caused delays to the flow of goods.
For the refurbishment and repair of devices, it is the same story. When a device needs to be fixed or upgraded, time is of the essence. Ultimately, delays would impact patients who may be denied timely access to treatments.
The financial and administrative cost of doing business across borders is also a huge issue, particularly for SME-driven sectors like medical technology. If devices and diagnostics were subject to tariffs, the costs may impact businesses when considering whether to enter new markets.
Our strong view is that customs arrangements should be put in place to minimise the time taken to clear medical products or components across borders. Every effort must be made to avoid unnecessary duplication and disruption.
The clock is ticking but it is not enough to hope for clarity by 2019. Business leaders are making decisions now which will have far-reaching consequences for the future. A vital ingredient when deciding how to invest and which markets to prioritise is predictability.
We urge those on both sides of the negotiating table to prioritise patient safety, public health and the future competitiveness of a highly-innovative and job-creating industry.