EU Consultation: Uniform Application of Requirements for Notified Bodies – Have Your Say!

Posted on December 16, 2025 By MDSS
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The European Commission has launched a public consultation aimed at improving the uniform application of requirements for Notified Bodies under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

This initiative aims to address inconsistencies, which have created uncertainty for manufacturers across the world.

What Is Being Proposed? 
A draft Implementing Regulation introduces harmonised rules for how Notified Bodies operate, with a strong focus on:
• Transparency of quotations
• Predictable timelines
• More consistent re-certification practices

 

A key point of the proposal is that Notified Bodies may only issue quotations once they have received complete information from the manufacturer.

This explicitly includes:
[…] the notified body shall have documented procedures that ensure that it only issues quotations where it has received from the manufacturer the following information:
[…]
(c) name and address of the manufacturer’s authorised representative, where applicable;

 

This means that manufacturers without a clearly appointed and documented EU Authorised Representative may face delays even at the quotation stage, impacting certification planning and timelines.

Next Steps 
Stakeholders are encouraged to provide feedback via the Commission’s consultation portal. These changes, once adopted, are expected to significantly influence how manufacturers plan MDR and IVDR conformity assessments.

 

MDSS Insight

We support manufacturers as EU Authorised Representative and help ensure that all required information is in place early, avoiding unnecessary delays with Notified Bodies.

If you would like to discuss how this proposal may affect your certification strategy, contact us today!