But not all Notified Bodies will survice the process.
The European Union is currently re-assessing Notified Bodies against the new Medical Device and IVD regulations. This process, expected to take at least 18 months, is likely to result in a much smaller number of Notified Bodies, and the scope of activity for many will be reduced, leaving only a few authorised to assess the full range of devices including Class III and Active Implants and the highest risk IVDs.
The reduction is already happening. From a peak of around 80 Notified Bodies in 2013, there has been an accelerating decline, as some of the smaller ones lose designation or depart the field voluntarily. More are expected to follow: at the time of writing the number is around 50. The final number is likely to approach half that.
Lists of Notified Bodies and their scopes are available at Commission Website. See the separate lists for current scopes against the directives for Medical Devices, Active Implantable Devices and IVDs.
But what happens if your Notified Body fails to achieve re-designation, or has its scope narrowed – or just gives up and goes away?
Transitional arrangements are being developed. Firms with so-called “orphaned” manufacturers: where the Notified Body can no longer support assessment, will be allowed a period of grace to find a new Notified Body. The approach has been agreed at the European level and a common set of principles developed which require affected manufacturers to:
- notify national authorities within 4 weeks of learning that their Notified Body ceased to be designated
- provide a list of current devices supplied;
- undertake to maintain compliant quality systems;
- maintain postmarket compliance;
- provide information on plans to obtain recertification;
The waiver is typically for 12 months and may be conditional on there being no current safety issues with the device.
Implementation is however somewhat ad hoc. The current Directives are of course transposed into National Law. That means that it’s up to each member state to implement the arrangements to make to allow continued supply in its territory.
So what to do?
If your notified body has ceased operations, then be careful in your choice of a new provider. You don’t want to be jumping from the frying pan into the fire. Make sure you explicitly confirm their current scope and plans to seek re-designation. Given the current hiatus in Europe – all manufacturers should be speaking to their Notified Body and making absolutely sure that they will continue to be supported.
Links to National transitional arrangements for Orphaned Manufacturers.
Supplying in Europe? We are experienced in all aspects of CE certification and European compliance. Whether entering Europe for the first time, seeking transition to the new MDR/IVDR or needing to find a new Notified Body, we can help. Contact us today for a no obigation chat: email firstname.lastname@example.org or call +61 2 9906 2984