An indispensable analysis of Europe’s current guidance on clinical evaluations, MEDDEV 2.7/1, Revision 4
London-based medical device regulatory consultancy Quality First International has published the first extensive handbook on the clinical evaluation guidance document from the European Commission, MEDDEV 2.7/1, Revision 4.
London, 3 October 2018
Haroon Atchia, CEO and co-founder of the London-based medical device regulatory consultancy Quality First International has published a handbook on the European Guidance on clinical evaluations, MEDDEV 2.7/1, Revision 4.
This guide, which is directed in particular at regulatory affairs professionals dealing with European medical device regulations, helps to explain the principles of clinical evaluation, as well as the changes and new requirements introduced by the fourth revision of the MEDDEV guidance. Although MEDDEV 2.7/1, revision 4 is a guide for manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC, the recommendations contained in the guidance are closely aligned with the new Regulation (EU) 2017/745.
“Expectations about evaluation of clinical data have evolved dramatically. For these reasons, radical improvements were added or elaborated by the most recent revision of the MEDDEV guide. Consequently, it behoves our industry to understand precise status of such guidance, its intricacies and confounders; objectives and application; and its strengths and weaknesses”, states Haroon Atchia.
The handbook may be purchased from Quality First International, price: £399 (plus VAT as applicable), email: firstname.lastname@example.org to order a copy.
About Quality First International (QFI)
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, Mexican and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI’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. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.