Steps to sell in the UK
A UKRP guidance as per MHRA
With all the changes in UK medical device regulations, having a regulatory strategy is the first step to marketing medical devices in the United Kingdom. Our team of expert consultants in medical device regulations, specifically the UK Medicines and Healthcare products Regulatory Agency (MHRA), will guide you through this process. We as UKRP can help you.
Obtain the CE / UKCA mark
Manufacturers need to obtain CE /UKCA marking for all medical devices and IVDs before the products can be sold in the EU. This process includes generating a technical documentation file (TDF) and quality management system (QMS) based on the requirements of the MDR/IVDR. Once the evaluation has been carried out, the result will be a Declaration of Conformity.
Appoint UK Responsible Person (UKRP)
Non UK-Manufacturers must appoint an UK Responsible Person (UKRP). The medical device UKRP shares liability with the manufacturer for the product on the market and therefore plays a critical role.
The UK Responsible Person information must be part of the device label and Declaration of Conformity only when the device has a UKCA mark.
Register Company and Devices
Your company and medical devices must be registered in the MHRA. The registration must be done by the UK Responsible Person (UKRP).
Appoint an Importer
For selling your devices in the UK, it is mandatory to have an importer when you are not a UK-manufacturer.
Importers shall be identify in the medical devices documentation and in the Device Registration.
Your UK Responsible Person (UKRP) must guide you on how to obtain the correct importer.
The United Kingdom has undergone significant regulatory changes, particularly with the advent of Brexit and its departure from the European Union (EU). As a result, the MHRA has become the competent authority for medical device regulation in the UK. Navigating the UK-specific requirements and guidelines is essential for companies seeking to market medical devices in the country. Developing a comprehensive regulatory strategy is crucial to ensure compliance with UK regulations. Our experienced consultants specialize in UK medical device regulations and possess in-depth knowledge of the ever-evolving MHRA framework. We will analyze the applicable UK regulations, including product classification, conformity assessment procedures, technical documentation, post-market surveillance, and labeling requirements.
By partnering with our consultancy, you can streamline the regulatory approval process, optimize your time-to-market, and enhance your chances of achieving compliance swiftly and efficiently. We will assist you in assessing your device's classification and identifying the most suitable conformity assessment route, whether it involves a notified body or self-assessment. Our consultants will guide you in preparing the required technical documentation, such as the Technical File or Design Dossier, ensuring it aligns with the stringent UK regulatory standards.Furthermore, we will help you implement effective post-market surveillance strategies, including vigilance reporting and the establishment of a robust quality management system. By focusing on these crucial aspects, you can proactively monitor the safety and performance of your medical device throughout its lifecycle, demonstrating your commitment to patient safety and regulatory compliance.
AF Pharma consultancy services also extend to aiding you in meeting the labeling and translation requirements set forth by UK regulations. We understand the significance of accurate and compliant labeling, as it plays a crucial role in conveying essential information to healthcare professionals and end-users. Our consultants will assist you in ensuring that your product labels meet the necessary language, content, and formatting requirements, allowing for seamless market access within the United Kingdom.In summary, partnering with our team of expert consultants specializing in UK medical device regulations (MHRA) will provide you with invaluable guidance and support throughout your regulatory journey. By formulating a robust regulatory strategy and diligently addressing all pertinent UK requirements, you can navigate the complex landscape of UK regulations with confidence, ultimately ensuring a successful and compliant market entry for your medical device in the United Kingdom.