spacer
home > pmps > summer 2008 > recasting legislation
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Recasting Legislation

When the European Commission published its public consultation document concerning the recast of the current EU provisions governing medical devices on 7th May 2008, this did not come as a great surprise to the informed public. In its ‘Communication to the European Parliament and the Council’ in 2005 on Implementing the Community Lisbon programme the Commission had already indicated its intention to recast two of the three basic EU Directives governing medical devices into a simplified regulation.

While the subsequent proposal may have been “much awaited” (as the Commission’s own press release claimed) it was not in the form of a regulation. Moreover, there was a certain level of disappointment that the proposal, as finally submitted, did not constitute the overhaul of the existing medical device legislation that was hoped for in at least some corners.

No explanation as to the change of legislative approach was provided in either the impact assessment report for the Commission’s proposal or in the explanatory memorandum that accompanied the proposal. Moreover, even before the resultant modifications to Directive 90/385/EEC (1) and Directive 93/42/EEC (2) had been adopted, there were already rumblings that it was time for a complete revision of EU medical device law. While the EU member states are still implementing the last set of amendments to the medical devices directives, and manufacturers continue to determine the likely impact of these for their products, the Commission is proposing a revision of this existing framework in order “to improve and strengthen the legal framework for the regulation of medical devices in Europe”.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Elisabethann Wright has been practicing European law for more than 20 years. Her practice focuses largely on EU regulation of medical devices and pharmaceutical products. She has extensive experience in litigation before the European Court. Having successfully challenged decisions of the EU institutions before the European Courts, she also advises on EU law relating to government contracts.

Fabien Roy, a Legal Assistant in the Hogan & Hartson Brussels office, researches and assists in drafting legal opinions in the field of pharmaceutical law, and communicates regularly with the relevant authorities. He drafts reports on fields including: paediatrics, biosimilars, authorisation and control of pharmaceuticals, regulatory initiatives, oncology and diabetes. Fabien holds a degree of Public Law from the University of Silesia, and a Master’s Degree from the University of Rennes. Email: ewright@hhlaw.com

spacer
Fabien Roy
spacer
spacer
spacer
Elisabethann Wright
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Sphere Fluidics introduces latest version of Cyto-Mine Studio Software Suite

Cambridge, UK, 27 August 2019: Sphere Fluidics, a company commercializing single cell analysis systems underpinned by its patented picodroplet technology, today introduced an updated version of its Cyto-Mine® Studio Software Suite, a collection of software controlling operation of its Cyto-Mine Single Cell Analysis System, data acquisition and follow-up analysis. The latest software version includes new functionality to further enhance users’ workflows in biologics discovery and cell line development.
More info >>

White Papers

Running Better Trials Taking an Intelligent Monitoring Approach

Bioclinica

When it comes to implementing a risk-based monitoring program, it is not just about reducing monitoring visits and doing less Source Document Verification (SDV). It’s about bringing together your people, a solid process, and the right technology to run a better trial. Success with risk-based monitoring requires the ability to make sense of the thousands, if not millions, of data points captured by multiple disparate sources in a clinical trial. With the sheer volume of data generated on a daily basis comes complexity. How does one make sense of it all? Information overload burdens even the most experienced study teams who struggle to understand which data matters most and what it means.
More info >>

 
Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement