Notified body designation and oversight

This page is for notified bodies (NBs).

It explains our role for NBs and how a conformity assessment body can apply to become a NB.

What is a notified body?

NBs assess the conformity of products to applicable requirements before manufacturers place them on the EU market.

For some high-risk devices, NBs assess their conformity to the requirements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

If a device conforms to applicable requirements, a NB issues a CE certificate to the manufacturer. This allows the manufacturer to place their product on the EU market.

NBs can be identified on a device label with a unique 4-digit number.

Manufacturers can apply to any suitable EU NB.

HPRA role for notified bodies

We are responsible for NBs under the MDR and IVDR in Ireland.

If you are a conformity assessment body and would like to become a NB under the MDR and or IVDR, we must designate you.

After designation, we monitor and reassess NBs to ensure they continue to comply with requirements. This reassessment is similar to the designation process. As part of our monitoring activities, we:

• conduct audits of NBs in Ireland and of any subcontractors or subsidiaries in other countries,
• assess NB personnel performing QMS audits,
• review NB assessments of technical and clinical or performance evaluation documentation

We nominate experts to take part in joint assessments of NBs outside of Ireland. These teams are made up of experts from the European Commission and Member States.

Requirements for notified bodies

Chapter IV and Annex VII of the MDR and IVDR outline NB requirements. There are four main categories such as organisational and general, quality management, resource, and process requirements.

The Medical Devices Coordination Group (MDCG) endorses guidance which may help NBs to meet these requirements. You can find guidance on the European Commission's MDCG endorsed documents page.  

How do I apply for notified body designation?

We have a guide for the notified body designation process.

This guide provides information on how to submit an application to us, preliminary assessment reports, on-site assessments, and the decision on designation.

We have provided links to application forms and documents below as well as step by step instructions on how to submit them to us.

We encourage applicants to contact us to minimise delays in the process and to help with scheduling.

Step 1

• For designation under the MDR, you must complete an MDR Application Form.
• For designation under the IVDR, you must complete an IVDR Application Form.

Step 2

• Read and sign our Declaration of Completeness form.

Step 3

• Pay the relevant fees.
• We have a Guide to Fees for Human Products. This will help you to find the correct category of fee for submissions.
• This guide follows the order of the fees in our Fee Application Form. You should complete and include a fee application form with all submissions.
• We have Payment of Fee Instructions which provides details when paying fees by credit transfer or EFT.

Step 4

• Ensure that you provide a full listing of documents in support of your application in the Application Documentation Index Form.
• If applying under the MDR and IVDR at the same time, please submit separate applications.

Step 5

• Submit your document through the Common European Submission Platform (CESP). We have a Guide to Electronic Submissions. This guide has instructions for submitting documents through CESP.
• Support services are available for the CESP system at +353 1 634 3801 or cesp@hma.eu should you need help.
• If you have problems with submitting electronic applications using CESP, please contact us at devices@hpra.ie to discuss your situation before making an application.