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MHRA

The Medicines and Healthcare Products Regulatory Agency (MHRA), is the designated authority that administers and enforces the regulations for all medical devices within the UK, therefore manufacturers intending to market within the UK will need to adhere to the following regulations.

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What is MHRA

The Medicines and Healthcare Products Regulatory Agency (MHRA), is the designated authority that administers and enforces the regulations for all medical devices within the UK, therefore manufacturers intending to market within the UK will need to adhere to the following regulations.The Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)The General Product Safety Regulations 2005 (SI 2005 No1803)

The MHRA have complete oversight of all devices on the UK market and will implement vigilance, sampling, and reporting activities as well as managing incidents. Manufacturers located in the UK can register their products directly with MHRA. Although for manufacturers outside the UK will need to appoint Responsible Person within the UK to register their products.Registration information can be found here.

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MHRA Project Roadmap

CE marking will still be recognised by the UK for medical products until 1st of July 2024. From this date onwards, manufacturers that want to place their products on the UK market need to comply with the new already discussed UKCA marking. PeploBio will be able to support its customers with these new services, fulfilling the specification of a “third party conformity assessment” (this will need to be conducted by a UK approved body, as underpinned by the Medicines and Healthcare products Regulatory Agency (MHRA). This process almost mirrors the established procedure the European Union have for CE-marking.From 1st of July 2024, the MHRA have stated UKCA-marking will be based on Directive 90/385/EEC on active implantable medical devices (EU AIMDD) Directive 93/42/EEC on medical devices (EU MDD) Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)PeploBio will be able to apply its knowledge and experienced obtained by the third-party assessment activities demonstrated in the process of CE-marking - by transferring it and integrating it where necessary within the UKCA certification process, our accreditation and commitment to excellence serves to eliminate disruption and confusion for our trusted customers wanting to enter the UK market.

More about MHRA

FAQ

What is a UK Responsible Person?

For all non-UK based manufacturers who want to place their products on the UK market, they will need to appoint a “Responsible Person” to register their device with the MHRA. A UK responsible person (UKRP) has been defined as: "a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations”

You can find out more information here.

What is the Responsibility of a Responsible Person (UKRP)?

1. To register any new and existing devices a non-UK-manufacturer wishes to place on the market within the UK with the MHRA.

2. Ensure that their declaration of conformity and technical documentation have been developed and fulfil the criteria.

3. Ensure a copy is accessible for the required technical documentation including a copy of the declaration of conformity and certification.

4. Provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device when required.

5. It is the UKRP responsibility to liaise with the manufacturer, any requests made by the MHRA for samples of the developed medical device to be delivered.

6. The manufacturer and responsible person must have a structured system in place for any complaints and reports from healthcare professionals, patients and users about suspected incidents related to a medical device, and ensure they are effectively communicated to both parties immediately.

7. Work with the MHRA on any preventive or corrective measures needing to be actioned to eliminate an issue and/or mitigate the risks posed by a medical device.

8. Terminate the legal relationship with the manufacturer if the manufacturer acts contrary under these regulations informing the MHRA and, if applicable, the relevant notified body of that termination.

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