How to select a Notified Body for Europe
If you are looking to enter the European market and you manufacture a Class I (Sterile or Measuring), Class IIa, IIb or III device, you will need the services of a Notified Body, sometimes also called a Registrar. A Notified Body (NB) is an accredited organization that is recognized by the European Union to audit quality systems and test devices to make sure the company/product meets applicable standards (example: ISO 13485) and directives (example: Medical Devices Directive). Upon successfully passing an audit or testing, the Notified Body issues a report or certificate that demonstrates the company's compliance with applicable European laws. Companies pursuing the European market require an NB's involvement to acquire the coveted "CE Marking" certificate.
Before going farther, we should clarify the difference between a Notified Body and a Registrar. Both are used interchangeably but do differ. An EU Notified Body is authorized to conduct ISO 13485 audits and issue the CE Marking certificate based on the applicable Medical Device Directives. A Registrar also is authorized to perform ISO 13485 audits but cannot issue a CE certificate. Many companies have been unpleasantly surprised by Registrars that charged a good price on their ISO 13485:2003 registration audit, only to find out later that a Registrar could not issue CE certificates or get a company licensed in Canada.
Many businesses offer these services, but the most widely known European Notified Bodies serving the medical device industry include BSI, Intertek, Kema, MedCert, SGS, TUV and UL. Various smaller NBs with good reputations are out there as well, and you should not exclude them from your selection process.
Tips to Enhance Your EU Notified Body Selection
The evaluation of an NB should involve much more than a cursory evaluation of pricing. The selection of your Notified Body is a critical decision, since you will need to employ its services for years to come; therefore, you want an NB that will offer good service, fair pricing and an understanding of your device. Following are some tips to help narrow your decision.
1. Consider your future plans. If you are a US company looking to obtain the CE Mark, look into your crystal ball. Might your future plans involve an expansion to Japan, Brazil or Canada? Not all European Notified Bodies have a worldwide presence. If there is a reasonable chance you may expand to other markets in the future, be sure to select an NB that will be able to offer you certification in those markets-otherwise, you may be faced with the unpleasant reality of changing firms or working with a "partner" firm that your current Registrar has established in that market. This brings us to the next point.
2. Beware of partners. Smaller Registrars, while often are able to deliver excellent service, may say they can offer you service in those other markets. However, be sure to ask whether the "presence" a Registrar has in those markets is part of the company or a partnership it has established with another company. Sometimes those relationships are seamless and you will have no problems. In reality, though, you would still be dealing with two separate entities with two hands in the cookie jar-and that always raises the possibility for problems. Dealing with a company that has global reach may cost more but can be worth it, as the next point will illustrate.
3. Bigger is better-or is it? It depends on your goals. Having a large brand name as your EU Notified Body can have a direct impact on your ability to secure new contracts with overseas firms. This is not a concept unique to the device industry but rather a mere fact of business life. People pay more attention to (and pay more for) established brands, and if your company is trying to break into the Japanese market and you are audited by Acme Registrars, it could potentially work against you. On the other hand, many small to mid-sized European Notified Bodies are reputable and can sometimes offer faster service at lower prices than the big guys. Consider what matters to your company and your plans for the future.
4. Identify service needs before, during and after the sale. Make sure the company you select will provide the service you expect. Will the business return your calls or respond to your emails quickly? Did you receive the proposal quickly? How long will it be before the company can conduct a registration audit? How long will it take to issue a certificate or review technical files? If you need registration in markets outside Europe, will you be dealing with one contact in one office or calling different offices? You should be aware that many European Notified Bodies use contract auditors, and their ability to control an auditor's schedule is limited. Ask how many of the Notified Body's auditors are in-house versus contracted. While most firms use contract auditors-allowing them to have a bigger pool of talent at their disposal-you need to be cognizant of the downside. These are all important issues, and some are difficult to ascertain when talking to salespeople. Ask for non-competitor references and call them.
5. There will always be a few certainties of life: death, taxes...and extra fees. Everyone hates a surprise, especially when it involves money being extracted from his or her wallet. Before making your selection, ask the Notified Body if it charges any special administrative, renewal or address change fees. Find out how much it would cost to get extra copies of your CE certificate. Once you sign that contract, you will not have any choice but to pay those fees-it's better to know about extra fees now than to fume later.
6. Pick an EU Notified Body that has experience with your medical device. It is always good to ask the NB whether it has experience with your specific devices, especially if you manufacture a Class IIb or III product. Experience also is critically important if you manufacture a product for which classification in Europe is somewhat nebulous. In this case, you want the support of an NB that knows its stuff and can support your classification.
Reviewing Proposals from Notified Bodies
When you receive quotes from Notified Bodies, you will soon discover that prices can vary widely. Your price quote will depend on the size of your company, number of locations, complexity of your operation (for example, in-house sterilization), availability of auditors and the NB's experience with your specific device. All of these factors ultimately affect the number of audit days on-site.
The price quoted usually includes a registration audit plus semi-annual or annual surveillance audits-whether you select annual or semi-annual audits is up to you.
Another factor to consider is travel time, so ask where the auditor will be traveling from to conduct your audits. Some firms include travel in their quote; others do not. Many device manufacturers have been surprised to learn that their auditor is not based in the United States and will be flown in from Europe at your expense.
As a general rule, the bigger companies are often more expensive than smaller companies. Why? It's the same reason all well-known brands are more expensive than other brands, plus a few more. Larger Notified Bodies have more overhead, and the cost of maintaining their accreditation from their governing Competent Authority (CA) is higher. Most people do not realize that all Notified Bodies must be audited regularly by the CA. This includes "office" audits, whereby the CA visits the NB's office just as an NB would audit your facility, as well as "witness" audits, whereby a CA auditor tags along with an NB auditor to check his or her work. Furthermore, auditors for the larger companies need extensive training to maintain their knowledge of European regulations, along with those in Japan, Taiwan, Canada, Australia or other markets in which they are active.
The bottom line is that the selection of a European Notified Body is an important decision. Do your homework and check references. In the final analysis, though, never forget to pay attention to the most important factor: your instinct!
