Euro News

Switching Notified Bodies, Part II

Evangeline Loh

Last month’s column provided a refresher course on notified bodies—the 77 third-party organizations accredited and recognized in the European Union (EU) as capable of performing conformity assessment activities.

The column in the previous issue also briefly introduced a manufacturer who wanted to switch its notified body.

This issue examines the logistical considerations for this manufacturer and whether a change of notified bodies is warranted. Other questions to consider include: Should the decision to switch notified bodies be a fait accompli? What are some ways to enhance the selection of a notified body?

Reasonable Justifications to Change a Notified Body

What constitutes a reasonable justification to change a notified body? As with many things in life, reasonable is subjective. Thus, it is ultimately the manufacturer’s prerogative to switch notified bodies. If a manufacturer wants to make a change, the notified body should not hamper the change. The manufacturer is ill advised to switch if the reason is a difference in interpretation or position related to conformity assessment, compliance or a regulation.

Some reasons to change include:

1. Consolidation or divestment of organizations. As the last column explained, the manufacturer was being divested from a larger parent organization. In the current economic climate, more manufacturers are being divested or acquired, and this is an opportunity to switch or identify another notified body.

2. Acquisition of product lines. Perhaps a manufacturer acquires a line of medical devices that already possesses CE marking by another notified body. Perhaps the new medical devices are a higher classification risk, and it would be easier for the manufacturer to switch entirely to another notified body. Or, the manufacturer’s existing notified body may be incapable of CE marking, according to the new conformity assessment route. If the new line of medical devices doesn’t have CE marking, that would be another reason to switch notified bodies.

3. Notified body does not have global reach. The manufacturer wants to move into Canada and Japan, and the current notified body is unable to offer ISO 13485:2003 certification to the Canadian Medical Devices Assessment System or Japan’s Pharmaceutical Affairs Law Ministerial Ordinance No. 169. This is yet another consideration for selection of an appropriate notified body.

4. Poor customer service. Frustrated with the notified body’s poor response time, lengthy delays in reviews or lack of responsiveness? Switching notified bodies may not solve the manufacturer’s problems, though it is recognized that notified bodies should be more concerned about customer service and do a better job responding in a timely manner. But what constitutes timely? This also relates to selection criteria because the protracted communications may be due to the notified bodies’ requirement that headquarters make the decision.

Items one to 4 above are voluntary changes. There also are circumstances when the tables are turned and a notified body decides it doesn’t want to work with a manufacturer.

5. Enforced change or breakdown in the notified body. This situation occurs when the notified body is unable or no longer authorized to offer service. Manufacturers beware, however. It is predicted that the number of notified bodies authorized to review to the medical devices directives will decrease in the EU based on the European Commission’s (Recast Medical Devices Directives, May 2008) belief that a weakness in the current system is inconsistent designation and monitoring of the notified bodies.

Logistical Considerations

Logistical considerations are well described in the European Commission notified body Operational Group (NBOG) Guidance 2006-1 titled “Change of Notified Body.” For the same product, the MDD 93/42/EEC clearly doesn’t permit two applications or simultaneous applications with two notified bodies.

Also, the manufacturer is obligated to disclose finding differences between the first notified body and the second notified body. A contract between the parties clearly should delineate the change and discuss the following elements: date of invalidity of existing certificates, duties to inform, duties to label, responsibilities, property rights and regulations of costs. It is advised that the transition between use of the old labeling, brochures and marketing materials with the old notified body’s number produced while the CE marking certificate was still valid not exceed six months duration and can be negotiated under extenuating circumstances. Obviously, the labeling changes need to be documented and need to be correlated with specific production or batch numbers.

Tips to Enhance Selection

There are positives and negatives to switching notified bodies. The best advice is to spend sufficient time selecting the notified body. The six recommendations from the Euro News column in September 2006 remain salient: 1. onsider your future plans. What is the manufacturer’s future business and regulatory strategy? 2. Beware of partners. 3. Bigger is better—or is it? 4. Identify service needs before, during and after the sale. 5. There will always be a few certainties in life: death, taxes and extra fees. 6. Pick a notified body that has experience with your device.

Generally, proposals should be requested from three or four notified bodies. Schedule a call to discuss their technical expectations for the technical file/design dossier, and ask for their guidance on compiling a technical file/design dossier (MPO, June 2008).Does the notified body offer technical bulletins? What is the notified body’s Web site like? Select the notified body that is CE marking your competitor’s products. While this will not facilitate your review, it ensures the notified body has the experience necessary. Also, there should be no questions about the classification of the product.

Ask for references. Ask for references about the notified body’s responsiveness and customer service. Speak with regulatory and compliance colleagues for their perspectives and experiences. Agree upon timeframes or timelines for review and for the process to occur. Also make sure the notified body commits to the review times in writing (or confirm in writing).

Ask to schedule the date of audits and reviews before signing, and inquire about the availability of reviewers. Determine if the notified body possesses the resources necessary to assist. Also ask, who is in control, and where the work will be completed?

Selection of a notified body may depend on a member state competent authority’s position on the particular type of product. As an example, some notified bodies will accept tooth whitening products with greater than 6 percent hydrogen peroxide as a Class IIa medical device because their competent authority also endorses that position. Note that the competent authority may audit documents in the process of reviewing and qualifying the notified body. This also increasingly may occur with the greater emphasis placed on notified body competency.

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Notified bodies are involved in all but Class I self-certified medical devices. It is imperative that manufacturers wisely select a notified body to minimize issues later on. Careful research and consideration, particularly about future business and regulatory strategy, may minimize headaches after the fact.

Evangeline Loh, PhD, RAC, is vice president of regulatory affairs for Emergo Group, an international consulting firm providing regulatory, quality assurance and distribution consulting services. Emergo has offices in the United States, Europe, Japan, China, Canada, Mexico and Australia. Evangeline can be reached at [email protected].