Regulatory Open Forum

Options if your Notified Body stops.

There are several manufacturers that call us regarding the situation with their Notified Body (NB). What we see happening is that NB's drop-off before or during the designation under the MDR. Consequence is that manufacturers have to search for a new NB. If this happens the following scenarios can apply:

A) Rapid transfers

1. If your Notified Body is ECM, there is a rapid transfer possibility to TUV Nord. All manufacturers have been informed in due time.

2. If your Notified Body is UL, there is a rapid transfer to PCB. The manufacturers have been informed regarding this process.

3. If your Notified Body is SGS UK, there is a transfer to SGS Belgium at least when your devices have the correct scope to be covered by SGS Belgium.

B) Tri party dialogue:

It is possible is that a manufacturer enters into a tri party dialogue with their current NB and their potential new NB. They discuss together the details on a transfer from the existing NB to the new. It is very important that both NB's agree (on paper) regarding the requirements in this transfer process. Also important to have an external outsider help to manage this process. We recently helped a manufacturer that was in the renewal process with a NB, and during the renewal the NB stopped. The manufacturer agreed with another NB to take over the certs. However, during the process the new NB required that the old NB should first renew the certificates. This requires a lot of back and forth between the Notified Bodies and the manufacturer. An external independent consultant is a good option since in most cases the Notified Bodies have concerns regarding specific documentation. As outsider we can maneuver between manufacturer and both Notified Bodies to clarify requirements and speed up the process.   

C) Shepherding:

For this option the manufacturer does not have any time left to change certs. The possibility is that the manufacturer selects a new NB and prepares contract with them. Due to time constraints the new NB cannot review technical documentation before the deadlines. There needs to be a transition period for this manufacturer to go from one NB to another. This should be arranged with the competent authority of the country where the legal manufacturer is located or, if the manufacturer is located outside the EU, where the Authorized Representative is located. The manufacturer (together with Authorized representative, if applicable) needs to do a formal request to the competent  Authority (CA). The CA will grant temporarily permission. The CA will ask for details to the manufacturer. Part of the details are to show that the manufacturer is in good standing, a check on vigilance data, a check on outstanding regulatory issues. Once the CA has reviewed these there will be a decision to shepherd for a longer period until the manufacturer has completed the process with the new NB and receives certificates from the new NB.

There are a few considerations for this process:

• No changes to the devices since the CA does not have the process to review those
• CA's will accept these shepherding from each other based on informal NBOG agreement
• No guarantees

D) Start from scratch

If none of the above options can be used, the manufacturer needs to start from scratch with a new NB. The new NB will ask for technical documentation and will start the review process. Before certificates are issued the process  It will be hard to find a NB that will accept new customers for the MDD. There are 2 of which we are aware, those are ECM Italy and Szutest in Turkey. To help for MDD certificates they will charge additional costs on top of the normal costs. There is one option that is a practical approach while waiting on the new NB reviewing the technical documentation. To overcome the gap from expired certs to the new certs (either MDD or MDR) manufacturers can build inventory and take care it is in the distribution channel.

Please contact me for support.

• Have they applied for designation?
• Does their applicaiton cover your devices?
• Have they been inspected yet?
• When do they anticipate being Designated (and note that is only their estimate - some NBs have given up after not being able to resolve inspection NCs).

Continued reliance on Notified Bodies – rather than a centralized regulatory agency for Medical Devices, similar to the European Medicines Agency – has obviously not achieved the desired results hoped for by the EU member states and industry.  The concept of competition amongst Notified Bodies driving improvements in performance, when NBs are paid for by manufacturers, is tacit approval for incentivization of commercial considerations.  But placing the blame for a lack of readiness ahead of the 26 May 2020 deadline largely on the NBs is unfair when delays exist right across the landscape, including with Eudamed, harmonized standards, common specifications, etc.  There have been calls, from within the EU member states as well, to effectively allow existing medical devices cleared under the MDD to remain outside the new rules until at least 2024. While this exemption was intended to be used only for MDD cleared devices that have not undergone changes in design or intended use, or to devices that are re-classified to a higher risk classification under the MDR, the lack of readiness could result in disruption and shortages of other devices as well.  So yes, it's all a mess sadly, and the problem lies squarely at the doorstep of the European Commission. 

• Have they applied for designation?
• Does their applicaiton cover your devices?
• Have they been inspected yet?
• When do they anticipate being Designated (and note that is only their estimate - some NBs have given up after not being able to resolve inspection NCs).

Continued reliance on Notified Bodies – rather than a centralized regulatory agency for Medical Devices, similar to the European Medicines Agency – has obviously not achieved the desired results hoped for by the EU member states and industry.  The concept of competition amongst Notified Bodies driving improvements in performance, when NBs are paid for by manufacturers, is tacit approval for incentivization of commercial considerations.  But placing the blame for a lack of readiness ahead of the 26 May 2020 deadline largely on the NBs is unfair when delays exist right across the landscape, including with Eudamed, harmonized standards, common specifications, etc.  There have been calls, from within the EU member states as well, to effectively allow existing medical devices cleared under the MDD to remain outside the new rules until at least 2024. While this exemption was intended to be used only for MDD cleared devices that have not undergone changes in design or intended use, or to devices that are re-classified to a higher risk classification under the MDR, the lack of readiness could result in disruption and shortages of other devices as well.  So yes, it's all a mess sadly, and the problem lies squarely at the doorstep of the European Commission. 

• Have they applied for designation?
• Does their applicaiton cover your devices?
• Have they been inspected yet?
• When do they anticipate being Designated (and note that is only their estimate - some NBs have given up after not being able to resolve inspection NCs).