The limited capacity of the Notified Bodies is no secret and is expected to be further affected due to the newly accepted amendment. This can have a substantial effect on the response times and availability for work of the Notified Bodies, which ultimately means that the manufacturer must wait longer than usual for conformity assessments.
Due to the situation mentioned above, Advena has contacted all 37 MDR Notified Bodies to gauge their response times, availability for work and preferred type of initial engagement. The device that was used for this communication was a Class IIa dental device, more specifically dental drills.
From the 37 Notified Bodies that have been contacted, 16 or 43% have responded to us within 1 day of sending them an email. After 2 weeks, the number jumped up slightly to 21 equating to 56% response rate. A bar chart representing the exact response times can be shown below.
What was evident was that not all the Notified Bodies that have gotten back to us were available for work. From the 21 that have got back to us, a total of 12 Notified Bodies were available to take on work for the device in question. The remaining 9 were not available for work due to the limited capacity, or the scope of the Notified Bodies did not encompass the device in question.
The normal route and initial steps that need to be undertaken by the manufacturer to engage with the Notified Bodies involve the filling up of a questionnaire. This questionnaire is quite standard and contains questions such as the details of the manufacturer and authorised representative, contact details, questions regarding the device itself, technical documentation, and declaration of conformity.
This questionnaire is the preferred method of engagement with the Notified Body and would need to be completed for the Notified Body to provide an initial quote for their services. From the results obtained, the questionnaire was required by a total of 10 Notified Bodies. That being said, 2 Notified Bodies requested a call for their preferred method of initial engagement.
Although the Notified Bodies do seem to be in short supply, our brief study has shown that they are responsive. This is especially true in the early stages of contact, and this gives manufacturers the opportunity to contact sufficient numbers of Notified Bodies to get a feel for which to work with. Obviously, questionnaires and calls need to be made to drill down to the costs of each Notified Body and ultimately make an informed decision on which Notified Body best suits your situation.
Advena understands that these initial steps of engaging with Notified Bodies can be time-consuming and at times confusing. To facilitate these communications with the Notified Bodies, Advena can offer a service whereby we make the initial contact to gauge interest and even to complete as much as possible the questionnaires and calls on behalf of clients. If this is an area where you need assistance, please do let us know and we can discuss this further including our fees.
