Notified Body meeting report from BSI
26/04/2012
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.
