Do I need a UKCA or CE mark for my medical device?

Devices for the Great Britain market require UKCA marking (CE marking is accepted under the MHRA's transitional timelines), while devices for the EU market require CE marking under the EU MDR (or IVDR for in vitro diagnostics). Taylored Consultancy helps you determine the route and prepare the technical documentation.

How are medical devices classified?

Devices are classified by risk (Class I, I(s/m/r), IIa, IIb or III under UK and EU rules) based on factors such as duration of use, invasiveness, and whether the device is sterile or has a measuring function. Classification sets the conformity assessment route and whether a Notified Body (Approved Body in the UK) is involved.

Do I need a quality management system?

Most manufacturers need a Quality Management System, typically certified to ISO 13485, covering design, manufacture, risk management and post-market surveillance to demonstrate regulatory compliance.

Medical Devices

Making Medical
Devices Simple

Bringing a medical device to market means navigating complex regulations, technical requirements, and ongoing compliance obligations.

At Taylored Consultancy Ltd, we cut through the confusion and provide clear, commercially focused regulatory support to help you launch with confidence. Whether you need help with technical documentation, product classification, or quality management systems, we ensure your device meets UK and EU regulations without unnecessary delays.

Clearing the path to market -
regulatory and quality expertise that gets your medical devices approved, compliant, and trusted.

Client healthcare and skincare products with a stethoscope

What We Do

Biocompatibility Testing

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.

UK & EU Responsible Person Services

If you’re a non-UK or non-EU manufacturer, you must appoint a UK Responsible Person (UKRP) or an EU Authorized Representative (EC-REP). We act as your RP, ensuring your device remains compliant and meets all market requirements.

Clinical Evaluation Report (CER)

A CER is essential for demonstrating safety and performance. We help compile and review clinical data to support compliance with UK MDR and EU MDR.

Quality Management System (QMS) Creation – ISO 13485 & ISO 9001

We help develop and implement Quality Management Systems (QMS) that comply with ISO 13485 (specific to medical devices) and ISO 9001 (general quality management), setting you up for long-term compliance success.

General Product Safety Report (GSPR) Generation

We assist in generating and reviewing your GSPR to ensure your device meets all safety and performance requirements under the latest regulations.

No Drama, Just Compliance That Works

Medical device regulations can be 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.

Classification

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

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.

Gap Analysis

Already have documentation but unsure if it meets compliance standards? We conduct a full regulatory gap analysis to identify any missing or incomplete requirements.

Responsible Person Services for the UK, EU, and Australia

Already have documentation but unsure if it meets compliance standards? We conduct a full regulatory gap analysis to identify any missing or incomplete requirements.

QMS Internal Audit

We conduct internal audits to ensure your QMS meets regulatory and certification requirements, preparing you for external inspections and audits.

QMS Internal Audit

We conduct internal audits to ensure your QMS meets regulatory and certification requirements, preparing you for external inspections and audits.

Areas of Expertise

ISO 13485 - Medical devices
ISO22000 - Food supplements
GFSI/GFSI - Equivalent certifications (usually BRCGS, FSSC 22000, IFS) Food supplements
ISO 22716 - Cosmetics
ISO 9001 - General
EN 62304 - SaMD / software within a medical device
ISO 15378 - Medical packaging
ISO 22000 - Food supplements
ISO 11135 - Ethylene oxide sterilisation of medical devices
ISO 10993 - Biocompatibility
ISO 14971 - Risk management for medical devices
IEC 60601 - Electrical safety and electromagnetic compatibility for medical devices
ISO 14155 - Clinical investigation conduct
2014/53/EC - Bluetooth
FCC - Federal Communications Commission requirements for Bluetooth / Wi-Fi
ISO 15197 - Blood glucose monitoring systems
IEC 61326 - EMC requirements for electrical equipment
CLSI guidelines - Experienced support

Making Medical Devices Simple

What We Do

Areas of Expertise

Expanding into a new market?

Need expert help? Not sure where to start?

Making Medical
Devices Simple