Medical Devices

Medical Devices Compliance for Australian Companies Expanding to Spain

Medical device manufacturers in Australia seeking to enter the Spain market must comply with EU MDR 2017/745 and demonstrate conformity through comprehensive technical documentation. Spanish Agency of Medicines and Medical Devices (AEMPS) oversees medical device regulation in Spain, 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 Spain. 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

EU MDR 2017/745 Compliance

Full conformity assessment under European Medical Device Regulation, classification determination, and technical file preparation for Spain market authorization.

EC Representative Services

We act as your mandatory EU-established EC Representative (EC-REP), handling notifications, maintaining technical files, and liaising with Spanish Agency of Medicines and Medical Devices (AEMPS).

CE Marking & EUDAMED

CE marking affixing process, European Database on Medical Devices (EUDAMED) registration, and Unique Device Identification (UDI) system compliance for Spain.

Classification

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

Device Classification

Risk classification (Class I, IIa, IIb, III) determination and appropriate conformity assessment route selection based on device intended purpose and risk profile.

Technical Documentation

Complete technical file preparation meeting MDR Annex II/III requirements, including design dossiers, clinical evaluation, risk management, and post-market surveillance plans.

Notified Body Assessment

Notified Body selection, application support, and conformity assessment management for Class IIa, IIb, and III devices requiring third-party verification.

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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