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Five key steps to consider when entering the UK market

November 7, 2023

Entering the UK market as a medical supplier involves steps designed to ensure compliance with local regulations, quality standards, and market demands. Here are five key steps to consider:

 

1. Regulatory Compliance and Certification

  • CE Marking: Medical devices must have CE markings to be sold in the UK. This indicates that the product meets EU safety, health, and environmental protection requirements.
  • UKCA Marking: From January 1, 2021, a new UKCA (UK Conformity Assessed) marking has been introduced for Great Britain (England, Scotland, and Wales). This is similar to the CE marking but is specific to the UK.
  • MHRA Approval: The Medicines and Healthcare Products Regulatory Agency (MHRA) is the governing body for medicines, medical devices, and blood components for transfusion in the UK. Ensure that your products meet MHRA guidelines.

2. Market Research and Feasibility Study

  • Needs Assessment: Understand the specific needs and gaps in the UK healthcare system that your products can fill.
  • Competitive Analysis: Study your competitors, pricing strategies, and market trends.
  • Customer Segmentation: Identify your target customer base, whether it’s hospitals, clinics, or individual consumers.

3. Business Structure and Partnerships

  • Local Partners: Having a local distributor or partner can help navigate the complexities of the UK healthcare system.
  • Legal Structure: Decide whether to operate as a subsidiary, a branch, or through a partnership with an existing UK entity.
  • Contracts and Agreements: Ensure that all contracts, including those with distributors, suppliers, and partners, comply with UK law.

4. Supply Chain and Logistics

  • Warehousing: Decide on the logistics of storing your products within the UK or shipping them directly.
  • Transportation: Ensure your products can be reliably and quickly delivered to your customers.
  • Customs and Duties: Familiarise yourself with the UK’s customs regulations and any import duties that may apply to your products.

5. Marketing and Sales Strategy

  • Promotion: Utilise various channels like digital marketing, trade shows, and healthcare conferences to promote your products.
  • Sales Channels: Decide whether to sell directly to healthcare providers, through distributors, or online.
  • Customer Service: Ensure you have the necessary support to handle queries, complaints, and after-sales service.

The UK’s relationship with the EU and its internal regulations are subject to change, especially in the post-Brexit environment. Always consult with legal and market experts familiar with the current landscape to ensure you fully comply with all regulations and market demands.