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Scottish Health Innovations Ltd (SHIL) has launched a new regulatory advice service to support NHS Scotland navigate significant changes in medical device regulation. The service will also extend to companies or universities working in partnership with NHS Scotland to develop medical devices, ensuring high-quality advice and support is available across the health community.

Two new European regulations (Medical Devices Regulation (MDR) EU 2017/745 and In-vitro Diagnostic Medical Devices Regulation (IVDR) EU 2017/746) are replacing three existing directives (Directive 90/385/EEC Active Implantable Medical Devices (AIMD), Directive 93/42/EEC Medical Devices (MDD), and Directive 98/79/EC In-Vitro Diagnostics (IVD)) in the years up to 2022, starting with MDR in May 2020.

The new regulations have an impact on everyone involved with medical devices, from their manufacture to their use. The changes are significant and have a direct impact on NHS Health Boards and medical device manufacturers.

Graham Watson, Executive Chairman of SHIL comments:

“Medical devices are crucial in diagnosing, preventing, monitoring and treating illness, and overcoming disabilities. They play a key role in delivering new products that benefit the NHS, economy and, above all, patients. The new regulations reflect substantial technological and scientific progress in this sector over the last 20 years and are more stringent than the directives they replace.

“NHS Scotland Boards are not just involved in the procurement and use of medical devices; they also produce and manufacture medical devices for use in their own Health Board and further afield, which may result in them being designated as a legal manufacturer. It is therefore vitally important that all NHS Scotland Boards are fully aware of the changes and start preparing for implementation and compliance.

“With a long record of protecting the interests of NHS Scotland, our regulatory advice service extends the range of professional support offered by SHIL to accelerate innovation across NHS Scotland.”

SHIL operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive. Consultancy and advice is available to all NHS Health Boards, to ensure awareness and compliance with legal responsibilities, and to support the design and development of products under an accredited regulatory framework.

Elaine Gemmell, Head of Strategic Development at SHIL comments:

“This is a specialist area and it is important NHS Scotland, in addition to academia and industry, have access to high-quality advice and support.

“I encourage all Health Boards to familiarise themselves with the regulations and the changes. It is a legal responsibility to ensure safe, reliable products are used, and a compliant design and development process is followed in devices originating from NHS Scotland.”

A range of resources and guidance are available via SHIL, through our website, events or direct contact at

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