Module 15 Presentations

10/04/2024

Health Research Authority HRA Approval - align the Research Ethics Committee approvals process with what was NHS R&D approvals, to reduce duplication – now have a single HRA assessment

Major review of Research Governance Framework … the broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality across all aspects of healthcare in the UK and worldwide.

The Organisation for Professionals in Regulatory Affairs

49

UK MDR 2002

Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) Since the 1 st January 2021 Medical Devices are regulated under the above mentions regulation. This means that the Great Britain process are derived from the below EU legislation. Directive 90/385/EEC (EU AIMDD)

Directive 93/42/EEC (EU MDD) Directive 98/79/EEC (EU IVDD)

Tip: When designing a Clinical Investigation following the principals of ISO14155:2020 is good practice to have data that could satisfy global requirements.

The Organisation for Professionals in Regulatory Affairs

50