Regulatory Services for Medical Devices and IVDs in the United Kingdom
Navigate the regulatory landscape with confidence and compliance for market entry and product success
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UK Market
In the United Kingdom (UK), the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the medical devices market. Manufacturers can get their devices certified and demonstrate compliance with UK regulations.
All medical devices, including IVDs, custom-made devices, and procedure packs, must be registered with the MHRA before being placed on the UK market.
Services in UK Market
UKCA Marking
The UKCA (UK Conformity Assessed) marking is a UK product conformity marking that is required for certain products, including medical devices and in vitro diagnostic devices, placed on the UK market. The UKCA marking signifies that the product conforms to relevant UK regulations and...
READ MOREMDR and IVDR Compliance
In the context of medical devices, compliance with the Medical Device Regulation (MDR) & In-Vitro diagnostic Regulation is necessary for obtaining CE Marking. The CE Marking service for medical devices involves the assessment and evaluation of the device's conformity with the requirements of the...
READ MOREUK Responsible Person (UKRP)
A UK Responsible Person (UKRP) is a legal entity appointed by a manufacturer, based outside of the UK, to fulfil the obligations of the UK Responsible Person as per the UK Medical Device Regulations (UK-MDR) and In-Vitro Diagnostic Regulations (UK-IVDR). The UKRP ensures that...
READ MOREMHRA Regulatory Consulting
The MHRA Regulatory Consulting service provides expert guidance and support for medical device and IVD companies navigating the regulatory landscape in the UK. By leveraging the expertise of regulatory professionals, companies can streamline the process of gaining regulatory approval for their products and ensure...
READ MOREQuality Management System (QMS) – ISO 13485
ISO 13485 is the internationally set standard of quality management systems (QMS), issued by the International Standards Organization, for the manufacturing, design, installation, and servicing of medical devices. QMS UK is a service that provides quality management system solutions for manufacturers dealing in medical...
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