Notified Body Self Improvement

Notified Body Self Improvement

Evangeline Loh and Stewart Eisenhart

With 2011 half over, how many of us are still adhering to our New Year’s resolutions? If statistics are to be believed, few—if any are sticking to their guns. For the lucky few who develop objectives for which there are no metrics, who’s counting?

With the prospect of more prescriptive regulatory requirements on the horizon as part of the European Union’s recast of its Medical Devices Directives, European notified bodies have developed and made public a voluntary code of conduct in an effort to improve their system from within—and fend off having to comply with more heavy-handed rules from the European Parliament, Council and Commission.

As readers will recall from previous columns, notified bodies are third-party entities “notified” to perform certain activities by each European Union member state. (Notified bodies only are involved in certain classifications of medical devices. And, when involved in a certification process, a notified body’s four-digit number will appear with the CE Mark on a device’s labeling.) Periodically a complete list of notified bodies is published in the Official Journal of European Communities. This information also is cataloged in a searchable database on the European Commission website. Hence, a competency or directive can be selected; a procedure, article or annex can be selected; and then a search can be performed to identify notified bodies.

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.

The Details

On a high level, the code of conduct requires all signatories to comply with all recognized standards, directives and laws; be accountable to competent authorities for their actions; commit to continuous operational improvement; and comply with the accreditation standards of EN ISO 17021 and EN ISO 17025.

Key document componentsinclude:

• Qualification and assignment ofnotified body assessment personnel,including MDD-QMS auditors, productassessors and product specialists;

• Minimum timeframes for notifiedbody assessments, in addition to recommended methodologies for

determining such timeframes;

• Minimum requirements for thenumber of technical files that must beassessed;

• Recommendations for design dossierreviews;

• Rules for subcontracting; and

• Rules for certification decisions.

For many of these components, the code of conduct emphasizes the need for flexibility in terms of applying its requirements to each individual signatory in order to accommodate national regulations to which they must adhere. Such flexibility judiciously must be allowed, however, lest EU regulators interpret it as leniency instead.

Enforcement: The Key Ingredient

Whether or not the code of conduct actually has any teeth in terms of enforcement will go a long way toward convincing EU officials that notified bodies are serious about self regulation.

According to the document, a notified body must fully implement the code of conduct’s requirements within six months of signing. Retrospective implementation for existing contracts is not required; all new contracts and applications as well as re-certifications must meet code requirements within six months of signature.

Enforcement of the code will fall to a yet-to-be-formed board of compliance. Though the intentions are good, questions remain about who will make up the board as well as what specific powers the body will have to ensure compliance with the code of conduct. Perhaps the next draft of the code will include these crucial details, but until then, perhaps the NB5Plus Group should provide some idea of the proposed board’s mandate and members in the meantime. These details will demonstrate whether European notified bodies mean business regarding improved and more consistent performance, or if they’re simply maneuvering to draw less fire from EU regulators.

Specific enforcement measures, furthermore, also significantly will depend on how the code of conduct is implemented. According to the code authors, implementation could occur through adoption of the document into formal guidance by Competent Authorities or the European Commission, or through adoption of parts of the document into EU legislation addressing notified bodies. Team NB, the association of European notified bodies, also could add the code to its constitution, in which case the association’s management structure would oversee enforcement.

The NBOG and Questions of Relevance

Even if the details mentioned above had been included in the current draft of the code of conduct, how relevant would such an effort prove? Many of the issues the document purports to address have been under the purview of the Notified Body Operations Group (NBOG), an entity set up by EU member states and the European Commission in 2000.

The NBOG’s purpose, according to its website, is to improve performance of notified bodies via identifying and promulgating best practices both among notified bodies as well as organizations that oversee them. NBOG already has identified three areas for improvement to notified body operations: more specific mandatory criteria for notified bodies, specific criteria for designation processes, and a mandatory peer review system.

Particularly telling, perhaps, is the fact that NBOG provided no reaction to the NB5Plus Group’s issuing of its code of conduct in April. Given that the document submitted by the NB5Plus Group has a lack of targeted steps and details, questions of how relevant their code of conduct in its current form is should come as no surprise.

On the other hand, NBOG has stepped up its own efforts to improve Europe’s notified body system in recent months. The entity has already assessed 15 of the 25 European authorities currently responsible for designating EU notified bodies. NBOG plans to use these assessments to establish a set of peer review criteria and a harmonized reporting structure to improve communications between designated authorities. Clearly despite the NB5Plus Group’s new code of conduct, NBOG is pursuing its own ideas for how to improve notified body performance.

Incomplete Scope

Another factor affecting the viability of the notified bodies’ code of conduct is the breadth of the document’s scope—does it adequately cover all major components of notified bodies’ business activities? The more comprehensive the code’s requirements, the more convincing these firms’ intent to self-regulate would seem to outside observers.

But the code of conduct in its current, public version is not complete. This is because, according to Team NB, the association could not muster a majority of members to adopt the document as a requirement for membership.As such, the NB5 opted to sign on to the code and make it public while continuing work on the document for an October 2011 re-release designed (hopefully) to attract more notified body signatories.

If the NB5Plus Group cannot attract more adherents—or at least an NBOG endorsement of its efforts—it is difficult to envision a successful outcome for the code of conduct.

Issues that the next version of the code will need to cover include incorporation of the IVD Directive; defining and setting rules for review of devices using human or animal components; incorporation of conformity assessments described in MDD Annex III or AIMD Annex 3 as well as MDD Annex IV or AIMD Annex 4; discrepancies between different notified body reviews of clinical evaluations under MEDDEV 2.7.1; and rules for own-brand-labeling manufacturers.

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NB5 has two key goals to meet byOctober: adequately addressing the outstanding issues previously mentioned in an improved version of the code of conduct and achieving critical mass in terms of getting enough notified bodies to sign on to the rules in order to make them viable—and convince EU regulators that Team NB as a whole takes self improvement seriously.

One strategy to consider for New Year’s resolutions in 2012: Issue them a half-year later, in the summer of 2012.

Stewart Eisenhart is regulatory editor and Evangeline Loh, Ph.D., RAC, is vice president of regulatory affairs for Emergo Group, an international medical device consulting firm providing regulatory, quality assurance and distribution consulting services. Evangeline can be reached at [email protected].