Applications for Designation under MDR/IVDR

From 26 November 2017, a conformity assessment body can submit an application to the HPRA to be designated under the new Regulations as a notified body in Ireland. The designation process typically takes between 12- 18 months, after which notified bodies can begin to certify devices to the new requirements. During the transitional period, devices can continue to be certified and placed on the market according to the current Directives (see Article 120 of MDR and Article 110 of IVDR).  This means that the Medical Device and In-Vitro Diagnostic Medical Device Regulations will not be fully legally binding until 2021 and 2022, respectively.

The HPRA encourages applicants to make contact with us by e-mailing to ensure that any prospective applications are processed as soon as possible to minimise delays in the designation process and to assist with scheduling.

The HPRA can also provide details regarding the associated fees for applications in advance of an application. From receipt of a valid application, there is a 30 day completeness check conducted by the HPRA and at this stage the application is made available to the European Commission. Subsequently a Preliminary Assessment Report is compiled by the HPRA, the outcome of which determines whether or not to schedule an on-site assessment of the applicant’s premises in the state.

The on-site assessment is a joint assessment between representatives of the designating authority, national experts and the European Commission. Following the on-site assessment and completion of related corrective actions, a recommendation for designation is made and if successful, notification is made on the NANDO website. For more details regarding the designation process, please refer to the relevant HPRA Guidance Document.

When submitting an application, please complete all fields in the MDR Application Form and/or IVDR Application Form and read and sign the Declaration of Completeness form. Please also ensure that a full listing of all documentation submitted in support of the application is detailed on the Application Documentation Index Form. If applying under the MDR and IVDR at the same time, please submit separate applications. The fee application form must be completed and submitted with all applications. Please refer to the Guide to Fees for Human Products which provides further detail regarding the fee codes. Fee payment instructions are available here. In addition, please submit proof of payment with application submissions. 

We accept and strongly recommend all relevant documents to be submitted through the Common European Submissions Portal (CESP).

The Guide to Electronic Submissions – Medical Devices provides all necessary instructions for this submission method. Dedicated support services are available for the CESP system at +353 1 634 3801 or should you require any assistance.

Following validation of the application, the HPRA will contact you if any further information is required. If you have any questions or issues relating to applying for designation as a notified body at HPRA please contact us by e-mail or telephone +353 1 676 4971.