Notified body designation and oversight
This webpage describes the activities performed by notified bodies (NBs), 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 certain higher-risk medical devices and in vitro diagnostic medical devices (IVDs), NBs assess their conformity to the requirements of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) respectively.
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 device labelling with a unique 4-digit number.
Manufacturers can apply to any suitable EU NB.
HPRA role for notified bodies
We are the authority responsible for NBs under the MDR and IVDR in Ireland.
If you are a conformity assessment body and would like to operate under the MDR and / or IVDR, we must first designate you as a NB.
After initial designation, we monitor and reassess NBs to ensure they continue to comply with requirements. The reassessment process closely mirrors the designation process.
As part of our monitoring activities, we:
conduct audits of NBs in Ireland and of any subcontractors or subsidiary locations in other EU or third countries
assess NB personnel performing quality management system audits
review NB assessments of technical and clinical or performance evaluation documentation
We also nominate experts to take part in joint assessments of NBs located outside of Ireland. Joint assessment 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. The MDR and IVDR divide these requirements into four main categories including organisational and general, quality management, resource, and process requirements.
The Medical Devices Coordination Group (MDCG) endorses documents and guidance developed within relevant working groups including the Notified Body Oversight (NBO), IVD and Clinical Investigation and Evaluation working groups. These documents reflect the interpretation of the EU law jointly agreed by European authorities and provide guidance to NBs on how to meet the MDR and IVDR requirements. You can find these documents on the European Commission's MDCG endorsed documents page.
How do I apply for notified body designation?
We have developed a guide for the notified body designation process. This guide provides you with information on how to submit an application to us and provides details of key steps in the process including the preliminary assessment report, the on-site assessment, and the decision on designation.
We have provided links to relevant application forms and documents below as well as step by step instructions on how to submit them to us. We encourage all applicants to contact us to ensure that we process prospective applications as soon as possible to minimise delays in the designation process and to help with scheduling.
If you would like us to designate your organisation as a NB under the MDR, you must first complete an MDR Application Form.
If you would like us to designate your organisation as a NB under the IVDR, you must first complete an IVDR Application Form.
Pay the relevant fees.
We have published a Guide to Fees for Human Products. This guide assists applicants in identifying the correct category of fee to accompany 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 also published Payment of Fee Instructions which provides additional details when paying fees by credit transfer or EFT.
Ensure that you provide a full listing of documentation 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.
Submit your document through the Common European Submission Platform (CESP). We have developed a Guide to Electronic Submissions. This guide has instructions for submitting documentation through CESP.
Dedicated support services are available for the CESP system at +353 1 634 3801 or email@example.com should you need any help.
If companies have problems with submitting electronic applications using CESP, they should contact us at firstname.lastname@example.org to discuss their situation before making an application.