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MHRA Approves Two New UK Bodies for Medical Device Certification

MHRA announces two new UK Approved Bodies to certify medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, delivering increased capacity for the certification of the performance and safety of medical devices, for healthcare professionals and the public.

Case study finds regulatory challenges are affecting MedTech innovation in the UK

UK MedTech Innovation Hindered by Regulatory Challenges: Study

Medical device manufacturers assured of seamless UKCA and CE certification with TÜV SÜD's UK approved body designation – CIE

Intertek receives UK Approved Body Designation under Part II of the UK Medical Devices Regulations 2002

Intertek, a leading total quality assurance provider to industries worldwide, is pleased to announce that Intertek Medical Notified Body UK Ltd (IMNB UK Ltd) has been designated against the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) by the Medicines and Healthcare products Regulatory Agency (MHRA). With its designation, Intertek is permitted to conduct UKCA conformity assessments and issue UKCA certificates for a range of active non-implantable and non-active medical...

What the indefinite delay of the UKCA mark means for boat buying and selling

Alasdair Reay explains what the indefinite delay in the introduction of the UKCA mark means for the sale of second hand boats across the Channel

Equipment for explosive atmospheres regulations

Guidance for businesses on the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016.

BEIS publishes draft legislation to extend post-Brexit transitional arrangements for businesses | Hogan Lovells

On 6 September 2022, a proposed negative statutory instrument relating to Brexit was published by the Department for Business, Energy & Industrial Strategy (“BEIS”): the Product Safety...

UKCA marking: conformity assessment and documentation

How to make sure that your products are properly checked for conformity and your technical documents are managed correctly.