Did you choose your notified body correctly? An overview for medical device manufacturers

Most Medical device manufacturers, other than class I (non- sterile) who wish to place their devices in the European Union must as a first step identify a Notified body (NB) for certification and compliance.

The role of a NB that is recognized by the European Union, is to assess the Quality management system compliance to ISO 13485 and also review the technical files and Design dossiers compliance to MDD 93/42/EEC prior to certification. Though the manufacturers concentrate on pricing while choosing a Notified Body, there are several other important factors to be considered while making a choice.

The first and foremost criteria for choice would be to assess if the NB has experience with the type of medical device that you are manufacturing especially in the case of higher risk devices. Through this the review and understanding process could become simpler.

Obtaining certification from a bigger organization boosts the image of the product in a global market. They also have the capability to overcome challenges from National competent authorities. When your marketing plans are focused on the European Union alone smaller companies can assist in this at a lesser expenses.

Notified Body that has a global presence and assist in registration and certification for countries globally would be the best candidate when your plan is to market your device globally. Prompt responses to mails, calls and time for review and audit are other tips for identifying the best Notified Body.

The annex XI of the Medical Device directive lays down the requirements to be fulfilled by the Notified body. A reassurance to manufacturers has been initiated through the voluntary initiative Notified body code of conduct. Make sure your choice of NB has signed up for this.

Once the Notified bodies have been shortlisted from a list of more than 70 NB’s it lies in the pricing. Well established Notified Bodies have higher maintenance costs and internal training to maintain their credibility and quality. Switching between NB’S needs to be done with careful consideration considering the guidance Notified body operation group commission (NBOG). It is best to make a decision based on all the above factors.

The author recommends I 3 Consulting for expert advice and further information and knowledge.

Jeyadevi Rajesh is a regulatory specialist at I 3 Consulting, a leading firm specialising in CE and Fda submssions. Contact jr@i3c.com for further information.