Medical Devices

Medical Devices Compliance for UK Companies Expanding to Ukraine

Medical device manufacturers in United Kingdom seeking to enter the Ukraine market must comply with local medical device regulations and demonstrate conformity through comprehensive technical documentation. State Service of Ukraine on Medicines and Drugs Control oversees medical device regulation in Ukraine, requiring manufacturers to establish proper representation and meet stringent safety and performance requirements.

Taylored Consultancy provides complete medical device regulatory support for United Kingdom companies expanding to Ukraine. Our services include device classification, technical file preparation, clinical evaluation, UK Responsible Person (UKRP) or EC Representative (EC-REP) services, and ongoing post-market surveillance to ensure full compliance throughout your product lifecycle.

Technical File Creation

We compile and review your Technical File to ensure it meets all regulatory requirements, including design specifications, testing data, and risk management documentation.

Risk Management

We support risk assessments and management processes to help identify, document, and mitigate potential product risks in line with ISO 14971.

QMS Supplier Audit

Supplier compliance is critical for medical devices. We assess your suppliers’ QMS performance to ensure regulatory and quality requirements are met.

What we do

Device Classification

Comprehensive risk classification under Ukraine medical device regulations, conformity assessment pathway determination, and regulatory strategy development.

Local Representative

We act as your authorized representative in Ukraine, handling regulatory communications, maintaining compliance documentation, and managing authority interactions.

Quality System Compliance

ISO 13485 quality management system verification, manufacturing evidence compilation, GMP compliance documentation, and quality assurance systems for Ukraine approval.

Classification

Unsure how your product is classified? We determine the correct classification, ensuring you follow the right regulatory pathway.

Product Registration

Complete registration process with State Service of Ukraine on Medicines and Drugs Control, including dossier preparation, technical documentation, submission management, and authority liaison for approval.

Technical Documentation

Complete technical file preparation including device description, design verification, risk management, clinical evaluation, and manufacturing documentation for Ukraine.

Market Authorization

Conformity certificates, import licenses, market authorization applications, and ongoing post-market surveillance requirements for successful Ukraine market entry.

QMS Audit Support

Facing a Notified Body audit or regulatory inspection? We provide hands-on support to help you prepare, respond, and maintain compliance throughout the process.

Testimonials

Our happy clients say about us

Bethany has a wealth of experience in medical devices and is always providing a fantastic service. Having worked with Bethany on and off over the years I can safely say I would trust her regulatory advice. Thank you Taylored & the team!

The Cosmetic Regulator

We have been working with Bethany for 3 months now and are very impressed! She is super orgainsed, very knowledgable and does it all with a smile! Would highly recommend.

George Kruis

Amazing! Went over and above working longer hours communicating with suppliers and getting all the relevant info. Quick to find solutions and overall very helpful. Thank you!

Tom Attwood

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