Apparently there has just been a meeting of the Notified Bodies.
That was from a news shot from BSi. I added the bold to highlight what I think is the most significant part.
April 2012: Brussels, Medical Device Notified Body Meeting
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 Harmonization appear to have been resolved. Agreement to both standards being reconfirmed as Harmonized under the European regulations has taken place and will take effect by lifting the EC formal objections to their harmonization. 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 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 Harmonization appear to have been resolved. Agreement to both standards being reconfirmed as Harmonized under the European regulations has taken place and will take effect by lifting the EC formal objections to their harmonization. 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.


