Regulatory Alert: New Challenges in Clinical Data Evaluation for Medical Device Manufacturers Following Amendment of the Medical Devices Directive

London, United Kingdom, November 01, 2008 --( The amendments to Council Directive 93/42/EEC relating to clinical data, which will come into force on 21 March 2010, are already affecting manufacturers of medical devices in Europe. Quality First International is alerting medtech companies who have not yet acted on these changes, which are primarily contained in Article 15/Annex X of Directive 93/42/EEC, to familiarise themselves with the extended requirements and take appropriate measures to comply with them.

The Directive’s revised text introduces a definition for clinical data, and tightens up the wording relating to clinical evaluation so that it is now necessary for all medical devices. Therefore, even devices of low risk (Class I) must undergo some sort of clinical evaluation, albeit less rigorous than the clinical evaluation needed for a high risk device (Class III).

One of the significant implications for medical device manufacturers is that clinical data must now be used not only as the basis for the evaluation of adverse effects but also for the evaluation of the acceptability of the benefit/risk ratio (referred to in Section 6 of Annex I). The clinical evaluation should take account of any relevant harmonised standards, and follow a defined and methodologically-sound procedure.

“Quality First International can help manufacturers to compile scientific and clinical literature reviews for a wide range of medical devices in accordance with the European Directives on medical devices, notably Article 15/Annex X of Council Directive 93/42/EEC”, explains Haroon Atchia, CEO and Technical Director of Quality First International. “We are able to help manufacturers fulfil their obligations for clinical data by compiling evaluations, which is particularly useful for medical devices where conducting systematic clinical investigation in human subjects may be impractical, unnecessary or unethical because of the history of use (e.g. for older device technologies).”

About Quality First International:
Quality First International offers an efficient and cost-effective service for producing literature reviews, particularly because of the company’s technical and regulatory strengths in numerous areas, ranging from simple, non-invasive to complex, permanently-implanted, and even combination products. The company is also able to produce scientific and clinical literature reviews to support other regulatory jurisdictions.

“Strong technical and regulatory aptitude means that Quality First International can help to identify technological groups to permit combination into a single scientific and clinical literature examination report (i.e. on the basis of homology and analogy), thereby improving versatility and contain costs”, says Mr Atchia. “Further, we can accommodate the recommendations of various guidance documents, such as MEDDEV 2.7.1, and ensure correlation with the corresponding risk management according to EN ISO 14971.

Quality First International Limited (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. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting-edge, minimally invasive and cardiovascular products and implants.

Quality First International has compiled scientific and clinical literature reviews for, amongst others, orthopaedic prostheses, cardiac prostheses, intravascular and other stents, numerous catheters, implants for reconstruction, ventricular assist and cardiopulmonary perfusion, drug-device combinations, bio-polymers including hydrogels for wound care, regenerative medicine and also animal- or human-tissue products.

For further information:
Marija Capek, PR and Press Officer
Tel: +49 (0)621 166 2326

Quality First International
Marija Capek
+49 (0)621 166 2326