Q&A: GORDON HIGSON
Finding a Competent Notified Body
"Choosing a notified body is one of the most crucial issues facing a manufacturer," writes Gordon Higson in the second edition of The Medical Devices Directives: A Manufacturers' Handbook. In this interview, the consulting director of Quintiles-Medical Technology Consultants (Staines, Middx, UK) and chairman of ISO TC 210, offers advice on the selection process.
Q: Your book includes a checklist of factors to take into account when looking for a notified body. What do you consider to be the most important criteria?
A: I would say it's the competence of the notified body to assess a manufacturer's particular device or process. If you're making a sterile product, you will want to choose a notified body that has some expertise in the sterilization process, for example. How do you do this? You talk to them, you expect them to produce credentials and a track record.
Q: One potential obstacle for manufacturers that you draw attention to is the "shortage of skills available for conformity-assessment procedures."
A: That doesn't mean those skills don't exist. They simply don't exist within every notified body. But there are well-known bodies that [acquired] expertise in specific areas long before they were notified: BSI in the UK, for example, has assessed more companies against ISO 9001 than nearly all of the other notified bodies combined, and the German TÜVs are well regarded for the testing of electromedical equipment.
Q: I would guess that a manufacturer who has had products certified by a body like BSI or TÜV that has since been notified would have everything to gain by continuing to use that company's services.
A: Absolutely. If I were choosing a notified body, the fact that I have a relationship with a company I know and trust would impress me. The TÜVs, BSI, Italy's Institute of Superior Sanita have all been involved in testing against national standards for years, and the tests they have performed on a given product are not going to be miles away from what is required under the Medical Devices Directive. So you can expect a rather favorable attitude if you ask them to do only those additional tests required to comply with the essential requirements. When you go to a notified body that has not been involved in the certification of your product in the past, it will want to know who tested the product, against which standards, what sort of equipment was used, the types of reports that were issued
Q: You also stress that it's important to ask about any subcontractors used by the notified body.
A: Manufacturers certainly should ask how the notified body assesses the competence of its subcontractors. Where a clinical evaluation is required, for example, I would discuss with great care how the notified body intends to assess the results of the clinical trials. Few notified bodies possess the skills to process clinical information and they must hire skilled physicians on a temporary basis to make these assessments.
Q: What are your thoughts on the third-party review system? Will it prevail?
A: Well, it might not be proven at this stage, but it has worked well in the past. Third-party review worked quite well with a number of voluntary national regulatory systems that existed before the directive. These reviews are well-accepted guarantees or indications of the safety and quality of products, and I think that their existence and our experience with a third-party review process demonstrates that it can work quite well.
We have about 60 notified bodies right now, many of which have been notified for all products and processes, and I think that is rather ambitious. What I expect to see happen during the next five years is a reduction in the number of notified bodies and a much more careful definition of the types of products and processes they are competent to deal with. Once that has been accomplished, I think the system will work just fine.
For additional information about The Medical Devices Directives: A Manufacturers' Handbook or to purchase a copy, contact MTC-BRI International Ltd., Mallard Court, Market Square, Staines, Middx, UK; phone: +44 1784 461661; fax: +44 1784 461610.
