The Search for Self Improvement The document, “Code of Conduct for Notified Bodies under Di

The Search for Self Improvement

The document, “Code of Conduct for Notified Bodies under Directives 90/385/EEC and 93/42/EEC: Improving implementation of the European CE certification of medical devices through harmonization of quality and competence of Notified Bodies,” targets longstanding regulatory concerns that the nearly 80 notified bodies currentlyoperating across the European Union’s medical device market are not all operating at the same level of consistency.

The new code of conduct defines rules on work and staffing qualifications, as well as how notified bodies’ work should be conducted and harmonized. The documents’ authors and first signatories—BSI, TÜV Rheinland, TÜV SÜD, LNE/G-MED and DEKRA/KEMA, or the NB5Plus Group—argue that the code of conduct “will make obsolete the need for more drastic change to the legislative system.”
The firms further contend that the code of conduct will reduce current harmonization problems once a significant number of additional notified bodies sign on and comply.

“The signatory Notified Bodies aim to ensure a harmonized quality of work amongst the participating Notified Bodies, to gain trust in this work in public perception as well as from political and policy stakeholders, to contribute to ensure the trustworthiness of the system amongst international partners of the European Union and to support the reputation of the participating Notified Bodies,” according to the new document.

Establishing a more robust self-regulatory structure in an attempt to demonstrate good faith and (perhaps more importantly) lessen the brunt of external requirements from legislative bodies obviously is a key goal. The NB5Plus Group has argued that the current European legislative framework adequately can support an innovative medical device market as well as ensure patient safety.

“Notified Bodies are well suited and motivated to adapt rapidly to the ever changing technological needs, hiring sufficient competent staff and help make new technologies quickly available to patients through efficient and robust approval processes,” NB5Plus Group officials wrote.

This is hardly the first time an industry has proposed tighter operational requirements for itself in an attempt to preempt stricter regulatory action, but this tactic’s history of success has proven mixed. In NB5’s case, the effectiveness of this strategy largely will depend on how broadly the code of conduct is accepted among other notified bodies, as well as how meaningful the document’s compliance requirements are perceived to be among EU regulators who otherwise would write their own rules for this sector.