Euro News
Switching Notified Bodies
Evangeline Loh
Saddled with a notified body that is unresponsive and offers poor customer service? A manufacturer wanted to switch its notified body and recently sought counsel because it was interested in understanding the logistical ramifications. According to company officials, their corporation was being divested from a larger parent organization, and this was the perfect opportunity for them to disencumber themselves from the former notified body. In truth, they found the auditor of the notified body to be cantankerous, and they were more than happy to be rid of this individual and the notified body. Getting rid of a notified body solely because of the auditor is a little like cutting a finger off to get rid of a hangnail. Take note: For the appropriate reasons (not just because he or she is cantankerous), a manufacturer can request an auditor be removed.
The concept of switching notified bodies, hopefully, isn’t one that currently is being discussed in your organization. But if it is, a few recommendations might facilitate the process. This column last reported on the topic in the September 2006 issue of Medical Product Outsourcing, and we offered six suggestions to enhance notified body selection. The next column will expound more on the suggestions. For now, it’s back to the basics.
Notifying Whom of What?
A manufacturer of a Class I sterile or measuring Class IIa, IIb or III medical device will require the services of one of these esteemed organizations. A CE marking proffered by a notified body will be indicated with the “CE” and the four-digit identifying number of the notified body. The manufacturer also is issued a CE marking certificate by the notified body. (That said, beware of fraudulent notified body-issued CE marking certificates.)
Notified bodies are organizations accredited and recognized in the European Union (EU) as capable of performing conformity assessment activities within the different new approach directives, which provide for CE marking.
Why notified? The term notified body was coined because the EU member state designating authorities, or competent authorities who assess and qualify these organizations as competent to perform certain assessments, are “notified” by the EU member state to the European Commission as “bodies” capable of performing certain assessments.
The moniker notified body is described in Article 16 of the Medical Devices Directive MDD 93/42/EEC. This list is then published periodically in the Official Journal of the European Communities (OJEC) under a “List of Bodies Notified Under Directive 93/42/EEC.” In addition to the notified bodies’ name and address, this entry in the OJEC includes its identification number and comments about their responsibilities: types of devices, classes of devices and particular conformity assessment routes. Incidentally, each of the member state regulatory authorities will publish their lists. As examples, the competent authority in the United Kingdom, the Medicines and Healthcare Products Regulatory Agency (MHRA), publishes a list on its Web site. The German designating authorities, ZLG and ZLS (in the interest of preserving space the acronyms are not defined), publish their list in a report.
How Many Notified Bodies Are There?
Each EU member state informs the European Commission of the bodies they have deemed competent to review according to a particular directive. As of press time, the New Approach Notified and Designated Organizations (NANDO) information system (described below), listed 77 notified bodies qualified for the MDD 93/42/EEC. And not all EU member states have informed the European Commission of bodies that are competent with MDD 93/42/EEC—five of the 27 EU member states. Ten of the EU member states were associated only with one notified body.
Are All Notified Bodies Identically Qualified?
How does one ensure consistency of notified bodies with so many EU member state competent authorities? The criteria for notified bodies are specified in the MDD 93/42/EEC, particularly in Annex XI. The European Commission certainly didn’t feel that notified bodies were consistently designated and monitored by the EU member states (see “Euro News” in MPO, July/August 2008).
There are two working groups within the European Commission that attempt to address the consistency issue: the Notified Body Operational Group (NBOG) and NB-MED. NBOG is composed of representatives of the EU member state Competent Authority or designating authority. NB-MED is the notified bodies group that consists of notified body representatives, as well as invited stakeholders.
A seminal guidance published by NBOG is a Designating Authorities handbook. This 110-page document is touted by NBOG as a best practice guide or a practical aid for Designating Authorities and their staff. Further, NBOG issued the Brdo Resolution (named for where the meeting took place—Brdo, Slovenia) in February 2008 affirming the member states’ competent authorities commitment to notified bodies, recognizing that notified bodies needed to be consistent, and tasking the European Commission to consider its responsibility in facilitating the task. NBOG also is developing a peer review system among the EU organizations that designate notified bodies in order to ensure consistency in the EU. And, while compliance of the notified body with the EN 4500 (ISO/IEC 17000) series demonstrates compliance with generic requirements for notified body accreditation, it alone is not sufficient to demonstrate competence to the MDD 93/42/EEC. MHRA has its own guidelines, titled “Requirements for UK Notified Bodies.”
NANDO
NANDO information system is a database operated by the European Commission that catalogs all the notified bodies and the directives that the organizations technically are qualified to review. The database allows searching by a few different variables: country, directive, body and notifying or designating authority. This system allows manufacturers searching for particular characteristics to identify a few suitable candidates.
As with any system, one criticism was the lack of consistency in providing harmonized listings of the notified bodies’ skills. Thus, NBOG issued a recent guideline (NBOG PBG 2009-3), which is expected to help solve this problem. Note that the document proposes codes correlated with categories of devices (MD 0106 non-active instruments, MD 1111 software).
Conclusion
With 77 notified bodies, how does a firm select (or switch)? And, if switching notified bodies, what must be considered? It should be noted that with the political pressure that exists, it is expected that the number of notified bodies will decrease in the future. For more details, don’t miss the next issue.