NREC-MD reviews clinical investigations of medical devices – Medical Device Regulation (MDR; EU No. 2017/745) and performance studies of in vitro diagnostic medical devices – In Vitro Diagnostic Medical Devices Regulations (IVDR; EU No 2017/746).

Studies of medical devices which require ethical review by NREC-MD under MDR include:

• Clinical investigations conducted to demonstrate conformity of devices outlined in Article 62 of the Medical Devices Regulation (EU) 2017/745
• Post-market clinical follow up (PMCF) investigations regarding devices bearing the CE marking outlined in Article 74 of the Medical Devices Regulation (EU) 2017/745
• Substantial modifications to clinical investigations outlined in Article 75 of the Medical Devices Regulation (EU) 2017/745
• Other clinical investigations outlined in Article 82 of the Medical Devices Regulation (EU) 2017/745

Studies of in vitro diagnostic medical devices which require ethical review by NREC-MD under IVDR include:

• Performance studies outlined in Article 58 of In Vitro Diagnostic Medical Devices (EU) 2017/746
• Performance studies regarding devices bearing the CE marking outlined in Article 70 of In Vitro Diagnostic Medical Devices (EU) 2017/746
• Substantial modifications to performance studies outlined in Article 71 of In Vitro Diagnostic Medical Devices (EU) 2017/746

Applicants should determine if their study meets the scope of NREC-MD review; however where an Applicant is in any doubt as to whether their study falls under the MDR or IVDR, applicants are advised to consult with the HPRA (devices@hpra.ie).

The NREC-MD reviews:

• clinical investigations of medical devices as defined in the EU Medical Device Regulation (MDR; EU No 2017/745).
• performance studies of in vitro diagnostic medical devices as defined in the EU In Vitro Diagnostic Medical Device Regulation (IVDR; EU No 2017/746).

If a study falls under one of the above, you will need to apply for NREC-MD approval. Applicants should determine if their study meets the scope of NREC review; however where an applicant is in any doubt as to whether their study falls under the MDR or IVDR, applicants are advised to consult with the HPRA (devices@hpra.ie).

No; the EU MDR (EU No 2017/745) and IVDR (EU No 2017/746) have been applicable in Ireland since 26th May 2021/2022.

Applicants must therefore submit their applications for research ethics review to the NREC-MD, which can issue a single, nationally applicable ethics opinion in line with the MDR/IVDR.

Submission of a Substantial Modification must be accompanied by the NREC  form, any relevant documentation as designated by the form, and evidence of fee payment.

Further details on Substantial Modifications can be found here.

Please see our website here for details on submitting a new application for review to NREC-MD and here for details on submitting a substantial modification to NREC-MD for review.

All applications should be sent as a zipped folder to devices@nrec.ie.

No, combined studies (where a study includes both investigative medicinal product and medical device or in vitro diagnostic medical device) are subject to review by both NREC-CT and NREC-MD. Therefore, a separate full application to NREC-CT and NREC-MD is necessary. Further information about applying to NREC-CT is available here.

The National Office, in consultation with the NRECs and external stakeholders, have developed a national template for Sponsors to demonstrate compliance with all applicable data protection legislation, including national legislation. The template aims to assist Sponsors with informing the respective NRECs of data protection compliance and associated ethical considerations.

When compiling an application dossier for NREC-MD, the sponsor is asked to submit a ‘Statement of Compliance’ template [Please see ‘Guidance on Statement of Compliance’] which addresses the requirement to demonstrate compliance with data protection legislation

Where a study specific Data Protection Impact Statement (DPIA) with sponsor/ site Data Protection Officer (DPO) input / proof of engagement is provided instead, the application will be deemed valid. However, the NREC-MD may still request a Statement of Compliance upon their review of the application.

In general, all applications should be accompanied by the following (as applicable):

• Study-specific insurance policy
• Products liability insurance
• Other organisational insurances such as employers’ liability, public liability, professional indemnity, cyber/data protection.

The NREC should receive an assurance from Applicants that there is adequate insurance / indemnity arrangements in place for the potential legal liability arising from the research, and consider provision in proportion to the risk for compensation or treatment in the event of injury, disability or death attributable to participation.

NRECs are not expected to undertake detailed expert scrutiny of the insurance policies pertaining to the research described in the application they review. The responsibility for ensuring that cover is sufficient and adequate for the duration of the study lies with Applicants themselves.

For more information please review the State Indemnity Guidance (SIG-10) published by the State Claims Agency.

For information on fees please refer to  https://www.nrecoffice.ie/apply-2/fees/.

Applicants must pay the relevant fee in advance of submission to the National Office for Research Ethics Committees.

Please note that fees are reviewed annually.

When completing the Statement of Compliance, the sponsor’s DPO should comment on the data protection risks and mitigating safeguards being implemented in accordance with all applicable data protection legislation for the specific study.

The sponsor is also asked to note any engagement with the lead site DPO. Where a sponsor has been unable to obtain site DPO input, proof of engagement upon application is sufficient to be deemed valid. Upon review, the NREC-MD may issue a request for further information or issue a condition that DPO input must be obtained and implemented prior to initiation of the study.

The timelines for NREC-MD decisions are consistent with those required by the regulation for medical devices (EU No 2017/745) and in vitro diagnostic medical devices (EU No 2017/746).

The NREC-MD endeavours to issue an ethics opinion within a period of 55 days from the date of acknowledgement of a valid new application and 45 days of a valid substantial modification.

As of the 1st of July 2024, the National Office no longer requires the submission of Safety Reports for clinical investigations and performance studies. Applicants must ensure that all relevant regulatory reporting requirements to the Health Products Regulatory Authority (HPRA) have been met.

In line with good clinical practice and best practice, protocol deviations should be notified to the NREC-MD via email to devices@nrec.ie. Applicants should also ensure the National Competent Authority, (The Health Products Regulatory Authority (HPRA)) have also been notified.

Following this, it may be necessary to submit the deviation / change as a substantial modification for review.

All documentation submitted for NREC review must be presented in an accessible and searchable format (Word or original PDF). We are unable to accept scanned documents as these documents are composed of images, rather than searchable text, and cannot be optimised for use with assistive software. If it’s not possible to submit an accessible document due to a scanned wet ink signature, an unsigned accessible version must also be included as part of the submission. Submissions that are not in an accessible format may be deemed invalid or may delay the assessment process.

All applications submitted to the NRECs for ethics assessment must demonstrate compliance with the requirements under the Health Research Regulations 2018, as well as any other national or European legislation relevant to the study. Below are some examples of the key safeguards from the HRR 2018 that all studies must comply with:

1. Ethics review

Any processing or further processing of personal data for the purposes of health research requires ethics approval by a research ethics committee. This includes the re-use of study data for secondary research purposes when identifiable or pseudonymised data is used.

2. ‘Broad’ or ‘explicit’ consent for future use

The legislation allows for the use of ‘broad’ or ‘explicit’ consent in the processing or further processing of personal data for the purposes of health research. This legislation does not allow for blanket consent. Consent for future use of data must be limited to a particular disease area or more generally in that area or a related area of health research and must be clearly described in the Participant Information Leaflet. An example would be limiting future use of study data to the disease and / or medicinal product / device being studied.

3. Consent declarations

If your study involves participants that may lack decision making capacity, or you are unable to obtain explicit consent for the personal data being processed in the study, then an application for a consent declaration may be necessary.  The NRECs must be notified if a study requires a consent declaration as part of the application. This can be included in the Cover Letter or the Recruitment and Informed Consent Procedure. It is advisable to engage with the Secretariat of the HRCDC with any queries on this as early as possible in your project, in order to prevent potential delays.  secretariat@hrcdc.ie, www.hrcdc.ie

The Medical Devices team within the National Office are happy to provide pre-submission meetings with applicants where feasible. We ask that prior to the meeting, the applicant reviews our website and application documentation and prepares a list of questions for discussion. Please email devices@nrec.ie to arrange.

Where a clinical investigation / performance study is approved by the NREC-MD prior to receiving comments by the HPRA, in certain circumstances the sponsor of the study can inform the National Office of the changes by way of a notification rather than substantial modification.

This is provided the modifications are not considered substantial by the sponsor, as per Article 75 of the MDR (EU 745/2017) / Article 71 of the IVDR (EU 746/2017), eg do not involve substantial modifications to the protocol or participant facing documentation.

It is the responsibility of the Sponsor to determine whether a modification is considered substantial, but if unsure, please contact us on devices@nrec.ie or the HPRA at devices@hpra.ie for advice.

All investigational devices and comparator devices, as well as all study related procedures should be provided to participants free of charge. No cost should be incurred by the participants either directly or indirectly (via insurance), in line with the EUREC statement on compensation of research participants.