16 May 2018

The Notified Body Conundrum and How to make the most of it


This Month (May of 2018) marks the one-year anniversary of the publication of the Medical Device Regulation 745/2017 (the MDR) and the 6 month anniversary of the date that Notified Bodies were first allowed to apply for designation under the MDR. The changing regulatory landscape will impact many areas of business for economic operators within the EU medical device industry and will present new challenges for the interactions between manufacturers and their Notified Bodies.

The MDR requires a structured method for handling for communication between manufacturers and other economic operators such as end users, distributers, importers, Competent Authorities and Notified Bodies. (Article 10:9) The relationship between manufacturers and Notified Bodies will change under the MDR as the Notified Bodies will now also be tasked with regulatory enforcement responsibilities.

Manufacturers will have to anticipate the significant changes and challenges that the Notified Bodies will face, in order to ensure that their own transition to MDR compliance will be a smooth as possible. The increased workload on the Notified Bodies will demand more time and resources to service each company. As a result, the demand for services from Notified Bodies will increase dramatically approaching full application date and the shortage of available personnel will likely cause delays and restrictions of services offered. Communication will have to be maintained and planned far in advance, as the decrease in available Notified Bodies and their personnel will make the CE marking process a more time-consuming task. Applying for assessments early will lower the risk of postponements in assessments and CE mark approval. Delays could prove to be costly for companies who are not prepared for full application or apply late as products with no, or expired CE marks will not be available to the market until they receive the MDR certification. The transition period from the MDD to the MDR is now a third of the way complete, businesses who are using this time to build a strong working relationship with their Notified Body will be at a distinct advantage over their competitors as the transition period draws to a close.

What can we do?

Building a strong relationship with your Notified Body will be an integral part of your transition to MDR. There are some important questions to ask your Notified Body in order to fully prepare your business for the coming changes.

  1. “Have you (The Notified Body) applied for designation under the MDR?”

The amount of Notified Bodies designated under the MDR will be less than there were present under the MDD, although some Notified Bodies such as TUV Sued and BSI have claimed confidence that they will receive designation. The designation process has been estimated to take between 18 and 24 months. Notified Bodies that have not been designated will be unable to grant MDR compliant CE marks until they receive designation, therefore it will be important to align early with your preferred Notified Body to ensure that they have the capability to work with you as the transition date draws closer.

  1. “Have you applied for the same scope of coverage?”

The increase in workload on the Notified Bodies will mean that some have applied for designation that will provide assistance with only specific or smaller range of devices. It is important to align early with your Notified body to ensure that they are designated for the appropriate range of products that your business produces.


Extra Questions for you to ask your Notified Body

“Will you have the required resources to support our business?”


“When do you estimate that you will be designated?”


“How do we as clients deal with opposing information from multiple Notified Bodies that we do business with?”


“Do you provide advice or training to your clients?”


“Where should we get our industry information from if not from our own Notified Body?”


“Will you be able to keep to your time commitments?”


“What are the challenges you see for yourselves in supporting your clients, and how are you dealing with these challenges?”


“What are your greatest risks?”