On 29 July 2014, the European Association for Medical Devices of Notified Bodies (TEAM-NB) issued a press release on its website to announce the release and immediate application of a new version of its Code of Conduct. The purpose of this voluntary Code of Conduct is to improve the implementation of the “certification of medical devices through clarified organizational criteria, management of competences and assessment practices“. The Code of Conduct, which is applicable to the twenty six notified bodies which are members of the TEAM-NB, includes guidance concerning the following elements:
- General principles of conduct;
- Implementation and monitoring of the Code of Conduct;
- Qualification and assignment of Notified Body assessment personnel;
- Minimum time for Notified Body assessments;
- Unannounced audits;
- Sampling of Class IIa and IIb Technical Files;
- Design Dossier Reviews;
- Verification of manufactured products for the In Vitro Diagnostic Medical Devices Directive;
- Rules for subcontracting;
- Rules for Certification Decisions.
Version 3.2 released
The changes introduced in this version 3.2 of the Code are listed in the press release of the TEAM-NB. These changes are considered as minor changes to put the Code of Conduct “in lines with European guidelines as well as wording which has been improved“. Most of these small changes are intended to bring the Code of Conduct up to date with the European Commission’s Recommendation 2013/473/EU of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices. This includes, for instance, the following changes:
- Section on unannounced visits geared to sampled products;
- Adjustments to frequency of unannounced visits for high risk devices, addition of sampling for Class Is/Im medical devices and self-test in vitro diagnostic medical devices under the unannounced visit scheme;
- Rewording of the need to visit subcontractors of virtual manufacturers.
Version 4 in preparation
More significant changes to the Code of Conduct are already in discussion at TEAM-NB. It has been reported that a draft of version 4.0 of the Code of Conduct is already out for comment until early September 2014. This version 4 of the Code would include amendments concerning the following elements:
- Auditor competence and training;
- Minimum time spent on Technical File reviews;
- Specific need to review of files under sampling regime; and
- Time needed for the review of Class I sterile devices under Annex II.
TEAM-NB would intend to adopt the document in October 2014. In light of the nature of the changes which are significant, it is expected that members of the TEAM-NB will benefit from a six-month transition period before application of the version 4 of the Code of Conduct.