CE marking

Please note this is an extract of the original bulletin. Medical devices: UK approved bodies* Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made: Updated ‘DEKRA Certification UK Ltd medical devices scope’. *Note: IVD devices are not in scope Medical devices given exceptional use authorisations during the COVID-19 pandemic…

Please note this is an extract of the original bulletin. Software and artificial intelligence (AI) as a medical device Page summary: Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD). Change made: Updated guidance to include reference to guiding principles on transparency for machine learning-enabled medical devices…

Please note this is an extract of the original bulletin. Our governance Page summary: The main decision-making, executive and managerial bodies at the Medicines and Healthcare products Regulatory Agency (MHRA). Change made: Updated board members and executive committee lists

Please note this is an extract of the original bulletin. Implementation of medical devices future regime Page summary: A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition. Change made: Updated to include intended policy on international recognition and consultation on common specifications for in vitro diagnostic medical…

Please note this is an extract of the original bulletin. MHRA announces dedicated new team to support the international community in tackling antimicrobial resistance Page summary: Backed by a new award of £1.8 million, the Medicines and Healthcare products Regulatory Agency (MHRA) is to establish a dedicated team to provide regulatory scientific support for innovators creating novel antimicrobials and diagnostics…

Please note this is an extract of the original bulletin. Update on pioneering initiative on regulation and evaluation of digital mental health technologies Page summary: An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals. Change made: First published.…

Please note this is an extract of the original bulletin. Impact of AI on the regulation of medical products Page summary: Implementing the Artificial Intelligence (AI) White Paper principles. Change made: First published. MHRA’s AI regulatory strategy ensures patient safety and industry innovation into 2030 Page summary: The MHRA has today set out its strategic approach to artificial intelligence (AI)…

Please note this is an extract of the original bulletin. Medical devices: UK approved bodies Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made: Added: LNE-GMED UK Limited in-vitro medical devices scope. LNE-GMED UK Limited active implantable medical devices scope Notify MHRA about a clinical investigation for a medical…

Please note this is an extract of the original bulletin. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…

Please note this is an extract of the original bulletin. Notify the MHRA about a clinical investigation for a medical device Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Added Combined review of a CTIMP and Medical Device section and accompanying guidance Combined IMP Device guidance Borderlines…