How to Choose a Notified Body

The right Notified Body will help device manufacturers accomplish current goals and long-term plans, which means that OEMs need to execute proper due diligence to find the best organizational fit.

Natural questions to ask include, does the Notified Body’s expertise and designation complement your device development goals, and will their level of service meet your standards? However, in the current environment, consolidation of the market both on the OEM and Notified Body sides need to be considered. Switching Notified Bodies, whether because of a product line acquisition or to expand into a new country, can be a timely and costly process.

At OMTEC 2013, questions arose about choosing the right Notified Body. Mr. Packard answers some of the questions attendees posed to him while at the conference.

Question: How many Notified Bodies (NB) will there be?

Mr. Packard's Answer: There are only 45 for orthopaedic devices now. I do not expect the number to drop below 12, but I do expect consolidation during the next five years. Merging NBs is very difficult, and transferring certificates from one NB to another is expensive and time consuming. I would expect most of the consolidation to be the result of NBs losing the right to continue to issue new certificates. The competition for technical reviewers will also be fierce.

Question: How do you select a Notified Body?

Answer: I make a short list and then request multiple quotes. Typically one or more of the NBs will do such a poor job of customer service during the quoting process that the list will be cut down to two or three quickly. I will only recommend one of the 15 registrars recognized for CMDCAS, and then I will use other factors to cut that list down to five to six candidates for my short list. Factors I consider are the number of technical reviewers for orthopaedics, the target countries in marketing in Europe and the client’s previous experience with NBs.

Question: Does the country of the Notified Body matter politically?

Answer: Technically it should make no difference, but it does make a small difference when you are marketing the product and trying to get distributors to partner with your company. Some NB numbers are well-recognized and others are not. If your company’s primary market is Germany or France, you may want to consider NBs from those markets. The Authorized Representative (AR) you pick may have a similar impact, because the AR’s name and full address appear on your labeling.

 

Continue reading: 

Voices from OMTEC 2013

Strategic Planning for Regulatory Compliance

The Post-Market Imperative