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Robin Blaney has broad experience in the life sciences sector including involvement in corporate, commercial, litigation, data privacy, and regulatory matters. He has gained particular experience in licensing, collaborative, and commercial transactions for life sciences clients. His regulatory practice includes pharmaceutical, medical device, food, and consumer product regulation.

On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance).  The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA).

The Guidance provides information on changes and protocol deviations that

This post originally appeared on our sister blog, InsideMedicalDevices.

The European Commission has proposed a revision to the regulatory framework for in vitro diagnostic medical devices (IVDs) that could have a significant impact on the operations of commercial laboratories in the EU or those offering testing services to customers in the EU.

Laboratory-Developed Tests

Under current EU rules, laboratory-developed tests (colloquially known as “home brew” tests) meet the definition of an IVD.  However, there is an exemption from the requirements under the current IVD Directive for certain laboratory-developed tests: Article 1(5) excludes from the scope of the Directive devices“manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity.”  ‘Health institution’ is not defined by the Directive, leading to significant variation in interpretation at the member state level as to when this exemption should apply, particularly in its application to free-standing commercial laboratories.
Continue Reading Proposed EU Rules Impact Commercial Testing Laboratories

This post originally appeared on our sister blog, InsideMedicalDevices.

On September 26, 2012 the European Commission adopted its long awaited proposals for the revision of the EU regulatory framework for medical devices.  Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro

Article originally published in PLC Life Sciences Handbook 2012

M&A in the life sciences sector has remained robust, driven by factors such as:

  • „„ The need to replenish shrinking product pipelines.
  • „„ The need to maintain revenues as patents on top-selling
  • products expire.
  • „„ The strategic diversification of business lines.
  • „„ Expansion into emerging markets.

Originally published as Covington E-Alert on June 15, 2011

The U.K. Department for Business, Innovation and Skills (BIS) has recently issued the final version of its guidance on the Agency Workers Regulations 2010, which implement Directive 2008/104/EC.

The Regulations come into force on 1 October 2011, and will entitle agency workers (or “temps”) to the

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

Article originally published in EURALex, issue 192, in March 2008

The European Commission has launched a consultation on proposed amendments to strengthen and rationalise the European Community (EC) pharmacovigilance rules and systems established by Directive 2001/83/EC and Regulation (EC) No 726/2004. Comments were sought from stakeholders by 1 February 2008. Grant Castle and Robin Blaney