Is there potential for abuse and mis-use of Recommendation 2013/473/EU by Notified Bodies and what are the implications for medical device economic operators?
London, 12 November 2014
Commission Recommendation 2013/473/EU on the audits and assessments performed by Notified Bodies in the field of medical devices was adopted by the European Commission on 24 September 2013. The Recommendation covers Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC and is intended to ensure proper verification of conformity assessments performed by Notified Bodies by tackling frequent shortcomings of audits, assessments and unannounced audits.
Haroon Atchia – CEO of the London-based medical device regulatory consultancy Quality First International – has written an article which explores the content of the Recommendation and exposes areas of possible abuse that could lead to the exploitation of economic operators in the field of medical devices.
“My enquiries to selected Notified Bodies have revealed non-uniformity in the expectation of unannounced visits, fuelled partly by a lack of comprehension of the Recommendation. One Notified Body explained, for instance, that contracted sterilisation would not constitute manufacture. Another considered that the right to an unannounced audit would be unnecessary if a sterilisation contractor possessed quality management system registration”, says H Atchia.
The article entitled “Is there potential for abuse and mis-use of Recommendation 2013/473/EU by Notified Bodies and what are the implications for medical device economic operators?” forms part of a series of publications by H Atchia that explore the issue. This first article has been published in the Journal of Medical Device Regulation, 2014, 11(4), 20-27. Future articles will be available on the QFI website upon release.
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.