Article originally published in the In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI), 2010

I. Introduction

This chapter discusses the European Union (EU) regulation of in vitro diagnostic (IVD) medical devices, covering both pre- and postmarket regulatory requirements. In order to understand these rules and the manner in which they operate, both at the EU level and at the national level, it is first necessary to provide an introduction to general principles of EU law and the manner in which the European legislators have sought to facilitate the free movement of a wide variety of products within the EU using so-called “New Approach” directives. This is followed by a discussion of the premarket regulation of IVD medical devices and then a discussion of postmarket regulation.

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Tags: EU Legislation, European Commission, Medical Devices
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Photo of Grant Castle Grant Castle

Grant Castle is a partner in the London office practicing in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation.

His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling…

Grant Castle is a partner in the London office practicing in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation.

His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management.  He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products.

He has developed considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, Russia, Africa, the Middle East, Japan, and Australia.  His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.

Grant is a visiting lecturer at the University of Surrey, on a course leading to a Master of Science in Pharmaceutical Medicine/Clinical Pharmacology; Cardiff University, on a course leading to a Master of Science/Diploma in Clinical Research and on the Postgraduate Course in Pharmaceutical Medicine; and, Cranfield University, on a course leading to Master of Science, Postgraduate Diploma, and Postgraduate Certificate in Medical Technology Regulatory Affairs.  Grant is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players” in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.”  He is praised by clients for his “absolutely first-rate” European regulatory practice.  Legal 500 UK notes that he is “‘highly competent in understanding legal and technical biological issues.”

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Photo of Robin Blaney Robin Blaney

Robin Blaney is a partner in the firm’s Life Sciences practice.  He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements…

Robin Blaney is a partner in the firm’s Life Sciences practice.  He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector.  His expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements, regulatory services agreements, and tenders.  He has particular experience structuring and documenting EU pharmaceutical distribution arrangements and transitional arrangements relating to product acquisitions.  Robin writes and speaks regularly on subjects such as medical device regulation, pharmacovigilance and clinical trials.

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