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MHRA medical device registration & clinical compliance

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  • usa United States +1
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Rate:
0
Publication date: 07.01.2026
Reading time: 7 minutes
Number of views: 28
Stage Term (days) Cost
  • 1
    Preliminary Regulatory and Legal Assessment of the Medical Device
    10 £1,082.40

    Lawyer’s actions

    Analysis of the type of medical device, its intended purpose, and method of use

    Determination of the applicable MHRA regulatory framework (UK MDR 2002 as amended)

    Preliminary classification of the medical device (Class I, IIa, IIb, III)

    Assessment of the need for clinical data and the level of clinical evaluation required

    Identification of regulatory and legal risks for entering the UK market

    Development of a step-by-step roadmap for MHRA registration and compliance
     

  • 2
    Preparation for Medical Device Registration with the MHRA
    12 £2,706.00

    Lawyer’s actions

    Advising on MHRA requirements applicable to the specific device class

    Legal review of technical documentation (Technical File / Design Dossier)

    Review of clinical evaluation reports and clinical safety data

    Assessment of compliance with the quality management system (ISO 13485)

    Preparation and/or review of the Declaration of Conformity

    Legal advice on product labelling and instructions for use

     

  • 3
    Registration of a UK Responsible Person
    7 £811.80

    Lawyer’s actions

    Assessment of the requirement to appoint a UK Responsible Person

    Drafting and review of the agreement between the manufacturer and the Responsible Person

    Legal definition of responsibilities and liability scope

    Registration of the Responsible Person in the MHRA system

    Advice on post-registration obligations

     

  • 4
    Application Submission and MHRA Medical Device Registration
    10 £1,623.60

    Lawyer’s actions

    Preparation and submission of the registration application to the MHRA

    Legal support for electronic submission via the DORS system

    Communication with the MHRA in case of additional information requests

    Legal amendments to documentation following regulatory comments

    Monitoring of application status and review timelines

     

  • 5
    Clinical and Post-Market Compliance
    12 £2,029.50

    Lawyer’s actions

    Legal support for post-market surveillance (PMS) obligations

    Review of incident reporting and vigilance systems


    Advice on mandatory reporting obligations to the MHRA

    Legal assistance during MHRA inspections and audits

    Updating compliance documentation following regulatory changes

     

In general
51 £8,253.30

Professional support for UK MHRA medical device regulation for your business

In today’s environment, entering the UK medical device market requires a clear understanding of UK MHRA medical device regulation and full compliance with regulatory requirements. The MHRA in the UK sets strict standards to ensure the safety, quality, and performance of medical devices. On the Consultant legal marketplace, you can find experts who will help you properly prepare documentation, complete registration, and ensure compliance with MHRA UK medical devices requirements.

Our specialists understand that compliance issues can be complex for many companies. That is why we offer comprehensive consultations on all aspects of UK MHRA medical device regulation, including risk analysis, preparation of technical files, and support throughout the entire registration process.

Responsible person registration: MHRA UK responsible person registration

One of the key steps for legally selling medical devices in the UK is MHRA UK responsible person registration. This process involves appointing a responsible person who ensures that products comply with UK MHRA requirements and acts as the main point of contact with regulatory authorities. Without successful MHRA UK responsible person registration, it is not possible to place a product on the market.

The Consultant marketplace helps you find a qualified lawyer or consultant to manage MHRA UK responsible person registration, including the preparation of all required agreements, documents, and registration data. This significantly reduces time to market and minimizes the risk of rejection.

Overview of regulatory requirements of MHRA in UK for medical devices

The MHRA in UK is responsible for implementing and enforcing UK MHRA medical device regulation, which includes:

  1. Review of technical documentation

     
  2. Assessment of clinical compliance

     
  3. Quality and safety control of products

     
  4. Post-market surveillance

     

Experts on Consultant help develop a compliance strategy for MHRA UK medical devices, including preparation of all documentation required for effective interaction with the MHRA in the UK. We provide support at every stage so you can focus on product development and growth.

Risk management: from paracetamol recall UK MHRA to complex cases

The quality and safety control system implemented by UK MHRA includes mechanisms for responding to non-compliant products on the market. One example is the paracetamol recall UK MHRA, where product recalls are conducted under regulatory supervision due to safety or compliance concerns. Such situations require not only technical solutions but also a well-structured legal strategy.

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Lawyers and consultants on our marketplace can assist with cases involving recalls, risk assessments, report preparation, and communication with MHRA UK medical devices. This helps minimize negative business impact and ensures full regulatory compliance.

 

Why choose Consultant for working with UK MHRA

The Consultant legal marketplace offers:

  1. Access to experts in UK MHRA medical device regulation

     
  2. Support with MHRA UK responsible person registration

     
  3. Consultation regarding MHRA in UK 

     
  4. Assistance with cases related to paracetamol recall UK MHRA

     
  5. Personalized support at every stage

     

We understand all the nuances of working with MHRA UK medical devices and help you avoid common regulatory mistakes. Choose Consultant for a safe and efficient entry into the UK market.

 

Conclusion

Medical device registration in the United Kingdom is a complex, multi-level process regulated by the requirements of the Medicines and Healthcare products Regulatory Agency. Successful market entry is possible only if regulatory rules are followed, products are correctly classified, technical documentation is complete, a responsible person is registered, and continuous post-market surveillance is maintained.

The legal marketplace Consultant provides comprehensive support at all stages—from initial analysis to assistance during inspections or product recalls. This approach enables companies to safely place MHRA-regulated products on the UK market while meeting the highest standards of quality and safety.

 

 

 

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Reviews
From Real Users

VS
Viktor Shevchenko

The legal support was clear and well structured. We appreciated that attention was given not only to documentation but also to clinical compliance and post-market surveillance. A solid service for companies working with MHRA.

NS
Nataliia Savchuk

We especially appreciated that the lawyers supported not only the registration process but also post-registration MHRA compliance. Their deep understanding of UK regulatory processes is evident.

MB
Mariia Bondarenko

A professional legal team that clearly explained all MHRA requirements and helped us avoid common mistakes. Thanks to their support, we successfully launched our product on the UK market.

IK
Iryna Koval

We received full legal support for MHRA medical device registration. All stages were clearly explained, timelines were met, and risks were minimized. A very professional and well-structured approach.

OM
Oleksandr Melnyk

The lawyers assisted with device classification and preparation of documentation for MHRA. The process was complex, but the team supported us at every stage. Overall, we were satisfied with the cooperation.

AL
Andrii Lysenko

We received high-quality advice regarding the responsible person and interaction with MHRA. Some stages took longer than expected, but the final result fully met our expectations.

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Calculate Service cost

  • Do you plan to register a medical device in accordance with MHRA requirements?
  • Do you need legal assistance with the classification of a medical device and the assessment of regulatory risks?
  • Does your company already have a registered Responsible Person (UK Responsible Person) to work with MHRA?
  • Are you experiencing difficulties in preparing technical and clinical documentation for MHRA?
  • Do you require legal support after registration, particularly regarding post-market surveillance and interaction with the regulator?
  • Is it important for you to minimize the risk of registration refusal or product recall from the market?
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