Clinical evaluation and performance evaluation of medical devices in the EU

Produced in partnership with Alison Dennis of Taylor Wessing LLP

Practice notes

Clinical evaluation and performance evaluation of medical devices in the EU

Produced in partnership with Alison Dennis of Taylor Wessing LLP

Practice notes

This Practice Note describes key changes to the requisite clinical evaluation and performance evaluation processes of medical devices under the EU regulatory regime introduced by Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), collectively referred to as the MD Regulations.

The MD Regulations introduce a major transformation in the assessment of the health and safety of medical devices through a formalised and heavily evidenced clinical/performance evaluation process that begins with the conformity procedure (CE marking) and continues throughout the entire Lifecycle of a device. This Practice Note considers the practical implications of the changes to the definitions and Requirements for clinical data, clinical evidence and, in particular, clinical investigations.

For further information on:

•
an introduction to the MD Regulations, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
•
scope and classification of devices, conformity assessment procedures and Notified Bodies, see Practice Note: The EU Medical Devices

Alison Dennis

Solicitor, Taylor Wessing LLP

Alison co-heads the international Life Sciences and Healthcare group at Taylor Wessing. She works with international life sciences companies to cut through the complexity of EU regulation of medical devices and pharmaceuticals and get their products to market.

In a career of over 20 years, Alison has helped hundreds of life sciences companies manage the range of legal challenges involved in commercialising medical devices and medicinal products. She combines an encyclopaedic knowledge of the EU and UK life sciences regulatory environment with an analytical understanding of strategy and business in the life sciences sector.

Alison provides sophisticated advice on regulation, compliance and commercialisation, as well as intellectual property transactions. On a number of occasions, she has successfully persuaded regulators and notified bodies to reconsider and ultimately overturn their decisions, allowing her clients to commercialise new products.

Alison supports clients on outright acquisitions and licences, as well as in due diligence for sizeable corporate transactions and listings. She also helps clients navigate the nuances of structuring and negotiating arrangements with various commercial and health care partners within the complex framework of EU regulations, national laws and industry and deontological codes.

Her clients praise the pragmatism and commercial awareness she brings to every legal challenge and transaction, as well as her bright and personable working style. She is an accomplished leader, having previously built new life sciences practices for two top-tier London law firms.

Jurisdiction(s):

United Kingdom

Key definition:

Lifecycle definition

What does Lifecycle mean?

The length of time that each item in the facility, such as plant machinery, fittings and equipment is required to last before being renewed or replaced.

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