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Do you need support with the UKCA mark?

AF Pharma offers comprehensive support for UKCA marking, assisting medical device manufacturers in generating the necessary technical documents and facilitating the registration process. Our expert consultancy team is well-versed in the requirements of the UK Conformity Assessment (UKCA) and can ensure that your medical device technical documentation meets the stringent regulatory standards. We provide guidance in creating accurate and compliant documents, including the medical device Technical File and Design Dossier. This is followed in order to demonstrate the safety and performance of your medical device. Additionally, we navigate the medical device registration process on your behalf, working closely with regulatory authorities to expedite the UKCA marking process and ensure a smooth path to market entry in the United Kingdom.  

By partnering with AF Pharma, you can rely on our consultancy expertise to navigate the complexities of UKCA marking, saving time and resources while ensuring medical device regulations compliance. We understand the importance of a robust and well-prepared medical device technical documentation package, and our services are designed to streamline the process for you. Trust AF Pharma as your dedicated partner to handle the intricacies of UKCA marking. We will enable you to focus on your core business while we take care of the regulatory requirements and facilitate a successful market entry in the UK.

Technical File for a UKCA mark

What is a Medical Device Technical File for a UKCA mark?

A medical device technical file for a UKCA mark is a set of technical documents that describes a product (medical device). It can prove that the product (medical device) was designed in accordance with the requirements of a quality management system. This is also used to obtain the UKCA mark in the UK and the UK Responsible Person (UKRP) must support you. 

Documentation for UKCA Technical Documentation

At a minimum, medical device technical documentation for obtaining the UKCA mark under the UK MDR 2002 should have:

  • A medical device description and specification section. 

  • Medical device labeling and instructions for use. 

  • Detailed information on design and manufacturing of the medical device.

  • Detailed risk management information of the medical device manufacturer in compliance with ISO 14971.

  • Essential Requirements (ES) for the UKCA marking for the medical device. 

  • Medical device verification and validation information.

  • Medical Device CERs (Clinical Evaluation Report) as per UK MDR 2002.

  • Post-market surveillance (PMS) information of your medical device.

Role of the UKRP in the UKCA mark

We can act as your medical device UK Responsible Person (UKRP) for the MHRA providing support to obtain your UKCA mark.

Also, as EU Authorized Representative (EC Rep) for the European Union.  

QMS - UKCA mark

Do I need a QMS for the UKCA mark medical device - class I?

The applicable provisions of the UKCA mark will be integrated into the QMS of the manufacturer. This will allow the correct assessment/decision to be made and the proper documented evidence to be created, ensuring compliance with the following requirements:

  1. Confirm product as a medical device.

  2. Confirm product as a Class I medical device. 

  3. ​Meet the general safety and performance requirements.​​

  4. Conduct clinical evaluation for the risk of the medical device under evaluation.

  5. Prepare technical documentation for the medical device.

  6. Request Notified Body involvement, if needed.

  7. Prepare Instructions for Use and Labelling for the medical device.

  8. Check compliance with general obligations for medical device´s manufacturers.

  9. Check compliance with general obligations for the medical device´s manufacturers.  

  10. Affix the CE marking for the medical device.

  11. Registration of medical devices and manufacturers in MHRA database.

  12. Post Market Surveillance (PMS).

    1. Review experience gained from Post-Market Surveillance.​

    2. Vigilance.

    3. Non-conforming products.

Do not forget about the timelines to comply with the UKCA mark!

We can act as your UK Responsible Person (UKRP) for the MHRA, as well as EU Authorized Representative (EC Rep) for the European Union.  

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