Medtech Regulations

MedTech Regulations for

Clinical Investigations

Medical Devices and In-Vitro Diagnostics are highly regulated. It is important to understand the classification and risk that your device poses and review and understand applicable general safety and performance testing required under European and Irish regulation for your specific device.

Further information is available in the Medtech Clinical Investigation Toolkit which is available upon request, here.

Medical Device Regulation (EU) 2017/745 (MDR)

In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR)

The MDR and IVDR regulations entered into force in May 2017. The MDR has been applicable since 26 May 2021 where the transition period was recently extended to the 31 Dec 2028. The IVDR has been applicable since 26 May 2022, where the transition period will end on the 26 May 2027.

Health Research Regulations (HRR) 2018, formally titled Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018.

Irish Medical Device Regulations 2021 (S.I. No. 261 of 2021) came into operation in May 2021 alongside the MDR. The regulation details how the MDR is implemented in Ireland and the functions and powers of the HPRA and the National research ethics committee.

HPRA Supporting Information on the MDR / IVDR Transition:

Factsheets and Infographics

MDCG Guidance Documents (MDR)

MDCG Guidance Documents (MDR and IVDR)

ISO14155: Clinical investigation of medical devices for human subjects – Good Clinical Practice (GCP)

ISO13485: Medical devices – Quality management systems – Requirements for regulatory purposes

ISO14971: Medical devices – Application of risk management to medical devices

ISO10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

EU General Data Protection Regulation (GDPR) was enacted in May 2016 and came into legal effect on 25 May 2018.

Health Research Regulations (HRR) 2018, formally titled Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018.

The HRB has prepared GDPR guidance for researchers.

GDPR introduces Data Protection Impact Assessments (DPIA) that are used to manage the risks of processing personal data. However, DPIAs are not always required.

European Commission provides Guidelines on DPIA and determining whether processing is “likely to result in a high risk” for the purposes of Regulation 2016/679.

Data Protection Commission (Ireland) provides a Guide to Data Protection Impact Assessments (DPIA).

The IMDRF documents support global regulatory harmonisation, previously known as Global Harmonization Task Force (GHTF), have produced the following technical documents that relate to clinical investigations: