Now available: Decoding European Union Medical Device proposal Regulation –What is new, what has been updated, what has been changed, which opportunities have been missed?
The internationally known Medical Device regulatory expert, Haroon Atchia has published the first fundamental and critical examination of the proposal Regulation
London, 25 April 2013
Haroon Atchia - CEO of the London-based medical device regulatory consultancy Quality First International - has written the first available in-depth examination of the proposal of a new medical device regulation in the European Union, as submitted by DG SANCO of the European Commission, Brussels.
The document offers an encompassing, one-stop access to the subject and facilitates examination and exploration of the proposed new regulation by dissecting the large proposal into discrete elements.
In his report Mr Atchia examines the questions:
- Which areas of the new regulation could present problems in efficient control of medical devices throughout Europe?
- What are the responsibilities of the different parties involved in manufacture, marketing, distribution and sale?
- What are the responsibilities and powers of the authorities involved?
- What are the changes from the prevailing Medical Device Directive 93/42/EEC (as amended)?
- Which opportunities for solving current regulatory problems have been missed by the Commission?
- Can real improvement be accomplished at all?
Title: Decoding European Union Medical Device proposal Regulation (COM
(2012) 542 final 0266 (COD)) – New requirements, changes, responsibilities,
implementation and missed opportunities
Specification: 336 pages, PDF, including tables and graphs.
Available for sale through: www.qualityfirstint.com, price: £299 plus VAT, as applicable
About Quality First International
Quality First International (QFI) is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. Quality First International provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. All submissions made by Quality First International have fulfilled the compliance requirements first time round, consistently. Quality First International’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants.
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