Medical Devices

Medical Devices Compliance for Australian Companies Expanding to United Kingdom

Medical device manufacturers in Australia seeking to enter the United Kingdom market must comply with local medical device regulations and demonstrate conformity through comprehensive technical documentation. Medicines and Healthcare products Regulatory Agency (MHRA) oversees medical device regulation in United Kingdom, requiring manufacturers to establish proper representation and meet stringent safety and performance requirements.

Taylored Consultancy provides complete medical device regulatory support for Australia companies expanding to United Kingdom. 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

UK MDR Compliance

Conformity with UK Medical Devices Regulations 2002 (as amended), classification assessment, and technical file preparation for UK market authorization and MHRA approval.

UKRP Services

We act as your mandatory UK Responsible Person (UKRP), handling MHRA notifications, maintaining technical documentation, and serving as your regulatory contact point.

UKCA Marking & Registration

UK Conformity Assessed (UKCA) marking process, MHRA device registration, manufacturer establishment registration, and ongoing compliance with UK post-market requirements.

Classification

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

Device Classification

Risk class determination (Class I, IIa, IIb, III) under UK rules, conformity assessment route selection, and regulatory pathway planning for UK market entry.

Technical Documentation

Comprehensive technical file including design documentation, risk management records, clinical evaluation reports, manufacturing information, and quality management systems.

Quality & Clinical Evidence

ISO 13485 quality management system compliance, clinical evaluation preparation, post-market clinical follow-up (PMCF) planning, and UK-specific vigilance requirements.

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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