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?
Summary
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.QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces.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.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.QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces.