Medical Devices
Bringing a medical device to the European market means meeting the full weight of the EU Medical Device Regulation (Regulation (EU) 2017/745) - technical documentation, clinical evidence and ongoing post-market obligations.
At Taylored Consultancy Ltd, we cut through the confusion and provide clear, commercially focused regulatory support to help you CE mark and launch with confidence. Whether you need help with technical documentation, product classification, or quality management systems, we make sure your device meets EU MDR requirements without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your medical devices CE marked, compliant, and trusted.
Unsure how your product is classified? We determine the correct classification under EU MDR (Annex VIII), ensuring you follow the right conformity assessment route.
If your device comes into contact with the body, it needs biocompatibility testing. We help you identify the right testing requirements and ensure results are documented correctly.
A CER is essential for demonstrating safety and performance. We help compile and review clinical data to support compliance with EU MDR.
We assist in generating and reviewing your GSPR checklist (Annex I) to ensure your device meets all safety and performance requirements under EU MDR.
Already have documentation but unsure if it meets compliance standards? We conduct a full regulatory gap analysis against EU MDR to identify any missing or incomplete requirements.
Your device's labelling and UDI must comply with strict EU MDR requirements. We review your labels and instructions for use to ensure all mandatory information is correct and compliant.
We handle device and actor registration in EUDAMED, ensuring your product is correctly listed before it enters the EU market.
If you're a non-EU manufacturer, you must appoint an EU Authorised Representative under MDR Article 11. We act as your EC REP, ensuring your device remains compliant and meets all market requirements.
Facing a Notified Body audit? We provide hands-on support to help you prepare, respond, and maintain compliance throughout the process.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
ISO 13485 - Medical devices
ISO 9001 - General
ISO 14971 - Risk management for medical devices
ISO 10993 - Biocompatibility
IEC 60601 - Electrical safety and electromagnetic compatibility for medical devices
ISO 11135 - Ethylene oxide sterilisation of medical devices
ISO 11607 - Packaging for terminally sterilised medical devices
ISO 15378 - Primary packaging materials for medicinal products
ISO 14155 - Clinical investigation conduct
EN 62304 - Software within a medical device
IEC 61326 - EMC requirements for electrical equipment
ISO 15197 - Blood glucose monitoring systems
2014/53/EU - Radio Equipment Directive (Bluetooth / Wi-Fi)
Get our instant-download EU Medical Device Regulations cheat sheet: classification, route to market and labelling essentials in one clear guide, for £15.
