Notified Body meeting report from BSI
Dr Gert Bos, Head of Regulatory and Clinical Affairs at BSI Healthcare has provided the following update.
The first Medical Device Notified Body meeting of 2012 took place last week in Brussels. Notified Bodies, the European Commission, Authorities, and industry representatives met to discuss the recently highlighted concerns with specific CE marked devices in Europe (i.e. PIP breast implants, metal on metal joints, and certain meshes).
The effectiveness of current European regulations and the full effectiveness of Notified Bodies has been under review. During the meeting, the European Commission strongly encouraged Notified Bodies to adopt the Code of Conduct, originally authored by five respected Notified Bodies, including BSI. To date, twelve of over seventy Notified Bodies, have now adopted the Code of Conduct.
Notified Bodies are also being advised to use their existing authority to conduct more unannounced inspection visits to manufacturers, conduct product sampling, witness device testing during audits, and perform market surveillance. Guidance is expected to be developed and issued to Notified Bodies on these practices soon. In order to support the recommendations, leading Notified Bodies have agreed to review, improve and confirm implementation of the Code of Conduct as required to immediately help address the concerns of stakeholders and the European Commission.
In other discussions, the issues around ISO 13485, ISO 14971, and EU Harmonisation appear to have been resolved. Agreement to both standards being reconfirmed as Harmonised under the European regulations has taken place and will take effect by lifting the EC formal objections to their harmonisation. The amendment of the standards to include revised and more specific Annex Zs to addressed doubts regarding the suitability of both standards to provide the presumption of compliance with the relevant requirements of the medical device directives.
The proposed revision of European regulation of medical devices continues to be on-track, but there are still significant discussions and debates in the coming months ahead and it is recommended to monitor future BSI email updates for progress reports.
BSI Healthcare is fully committed to supporting all initiatives to reinforce confidence, and where appropriate, make improvements to the European approach. We will be engaged, and represented in all relevant discussions. We are also committed to stimulate thought leadership, information sharing, guidance, developments, and decisions with our medical device manufacturer customers, and other stakeholders.
Dr Bos is Head of Regulatory and Clinical Affairs at BSI Healthcare and is certification manager at EUROCAT. He is chairman of the Notified Body association TEAN-NB, vice-chair of the Medical Notified Body forum NB-Med in Brussels, and participates in the Notified Body Recommendation group (NBRG), the Clinical Investigation and Evaluation Group (CIE), Medical Device Expert Group (MDEG) and the MDEG workgroups on animal tissue, on MRAs, e-labelling, EUDAMED and on IVDs.