Module 15 2022

20/05/2022

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 by UK and EU requirements.

The Organisation for Professionals in Regulatory Affairs

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Guidance

Medicines and Healthcare Products Regulatory Agency (MHRA) Medicines, medical devices and blood regulation and safety: Medical devices regulation and safety - detailed information - GOV.UK (www.gov.uk) Medical Device Coordination Group: MDCG endorsed documents - Medical Device Regulation (medical-device regulation.eu) MHRA – Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) Medical devices: EU regulations for MDR and IVDR (Northern Ireland) - GOV.UK (www.gov.uk)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

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