EU Medical devices regulatory

EU & FDA Medical Device Regulations – Enforcement Strategies

REPORT

1. CONTEXT OF THE PROPOSAL

The current EU regulatory framework for medical devices for in vitro diagnostic ("IVD") is given by Directive 98/79/EC of the European Parliament and of the Council ("IVD Directive") [1]. Among the IVD comprises a wide range of products that can be used for population screening, disease prevention, diagnosis, treatment monitoring and evaluation of prescribed medical interventions.

As the Council Directive 90/385/EEC on active implantable medical devices [2] and the Council Directive 93/42/EEC concerning medical devices [3], the IVD Directive is based on the "new approach" and aims to ensure the proper functioning of the internal market and a high level of protection of human health and safety. IVDs are not subject to pre-market authorization by a regulatory authority, but a conformity assessment, for most devices, it is carried out under the sole responsibility of the manufacturer. For high-risk devices listed in Annex II and devices for self-testing, conformity assessment involves an independent third party called "notified body". Notified bodies are designated and monitored by the United States and operate under the control of national authorities. A recognized device will comply bears the CE marking, which allows the free movement in the EU / EFTA and Turkey.

The current regulatory framework for in vitro diagnostic medical devices has proven its merits, but in recent years it has also been the subject of harsh criticism.

In an internal market with the participation of 32 countries [4] and that records constant scientific and technological progress, have revealed significant differences in the interpretation and application of standards and this compromises the main objectives of the Directive, which are the safety and performance of IVD and their freedom of movement.

The present review aims to overcome these defects and these differences and to further strengthen the safety of patients. There must be a strong regulatory framework, transparent and sustainable for in vitro diagnostic medical devices, which is adequate to the objectives pursued. Such a framework should be conducive to innovation and to the competitiveness of the in vitro diagnostic medical devices and ensure that the innovative IVD can enter the market quickly and efficiently in terms of cost, to the benefit of patients and healthcare professionals .

This proposal is adopted in parallel to a proposal for a regulation on medical devices which are currently covered by the Directive on medical devices and active implantable medical devices directive. Horizontal aspects common to both areas have been harmonized, while the specific characteristics of the sector of the IVD IVD and require the adoption of specific legislation, as distinct from the other medical devices.

2. CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENTS

In view of the impact assessment for this proposal and the proposal for a regulation on medical devices, the Commission held two public consultations, the first 8 May to 2 July 2008 and the second from 29 June to 15 September 2010. In both the public consultations have been applied to the general principles and minimum standards for consultation of interested parties by the Commission and takes into account the responses received within a reasonable time after the expiration of the terms. After reviewing all the answers, the Commission published a summary of the results and the individual responses on its website. [5]

Faqs on EU Medical Device Regulatory Affairs: Understanding the Directives and the Role of Key Participants Part 1
Book (Brookwood Medical Publications Ltd)
2013-03-20 12:19:34 by flaveur

"Obamacare" ..jobs destroyed in NY, WI, MA, etc.

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

2013-03-20 12:20:55 by flaveur

Um, it's actual closings and layoffs. Hello?

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

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