When a Medical Device crosses borders, it does not just need a passport. It needs compliance, representation, and a trustworthy hand to meet local regulations.
Lets look at some of the common mistakes companies make when selecting a UK Responsible Person and how to avoid them.
5 Mistakes To Avoid While Choosing a UKRP
Letting your European Regulatory Partner cover UK RP and UKCA Registration.
Asking your European CE mark or US FDA Regulatory partner to handle UKRP and UKCA is easy. Nevertheless, appointing Regen Marketing as your dedicated UKRP and UKCA registration partner will reduce your costs and create flexibility.
Appoint your UK Sales agent or Distributor.
Letting your local sales representative manage the UK regulatory side seems an easy option. However, it takes them away from sales. Choosing a dedicated UK Responsible Person also gives you the flexibility to change your sales representative or appoint additional distributors or agents to manage sales.
Ignoring the Importance of Communication and Quality Management
Choosing someone just because they are based in the UK is not enough. Poor communication can lead to misunderstandings and confusion. The UK Responsible Person you choose should be responsive, clear, and proactive in handling updates and regulatory notices. A dedicated UKRP will follow a set system that supports accurate documentation and timely submissions. Without strong internal processes, the representative may struggle to keep up with regulatory updates and technical requirements.
Selecting Based on Cost Alone
Focusing only on low pricing can lead to poor service, delayed responses, or a lack of proper guidance. The cheapest option may not offer full regulatory support. Paying slightly more often ensures better communication, reliable handling of compliance, and a stronger overall representation of your product.
Not Verifying Their Understanding of UK-Specific Rules
The UK has its own set of regulations, especially after Brexit. Make sure your representative knows the differences well. This includes having real knowledge of local standards and offering dependable UKRP services that match current MHRA guidelines.
Choosing the right UK Responsible Person is more than just a formality. It’s about placing your product in capable hands. A wrong choice may lead to compliance issues, legal trouble, or product delays. By avoiding the mistakes listed above, you can make a better decision and feel confident about your product’s path in the UK market.