Contact Us
Search Icon
Close up of male and female hands holding laparoscopic grasper with trocar

Medical Devices

Ensure patient safety while supporting timely market access to medical technology in a sustainable manner.

Our Mission

Our mission is to ensure patient safety while supporting timely market access to medical technology in a sustainable manner.

We strive to set the global standard through conducting impartial, responsive, robust and thorough conformity assessments, evaluations and certifications that are recognized and trusted worldwide.

BSI consists of 5,000 people supported by 12,000 industry experts in more than 193 countries. Our regulatory services combined with our world-leading experience provide efficient pathways to place your device on the market.

Maintaining quality and delivering excellence

BSI Medical Devices offers certification services to support your global market access goals. We are:

  • tick icon

    A leading full scope Notified Body (2797).

    Find out more
  • tick icon

    A leading full scope UK Approved Body (0086).

    Find out more
  • tick icon

    An accredited ISO 13485 Certification Body.

    Find out more
  • tick icon

    A recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP).

    Find out more
  • tick icon

    A Conformity Assessment Body and a registered Certification Body in many global markets.

  • tick icon

    Medical Devices & IVDs capacity and lead times applications and conformity assessments.

    Find out more
Scientist using a microscope
Services & Fees

MDR and IVDR Services and Fees

Download our fees for IVDR and MDR Conformity Assessments that are effective from 1 January 2024.

doctor and patient discussing

BSI Regulatory Services Certification Business Policy

BSI Assurance UK Ltd, BSI Group The Netherlands B.V. and BSI Group America Inc. are third party accredited /recognized certification bodies (UKAS, RvA and MDSAP) that supply management systems assessment and certification.

Our Experts

Our technical teams

Technical Team

Active implantable medical devices (AIMD)

Include Pacemakers, defibrillators, neurostimulators systems, cochlear implants, infusion pumps, implantable glucose monitors, MEMs and much more.

Technical Team

Artificial intelligence (AI)

Discover AI application to medical devices and ensure you meet the relevant regulatory requirements to enter this growing market.

Technical Team

General medical devices

Include implantable, wound and skin care, ophtalmic, infusion, transfusion medical devices and much more.

Technical Team

In vitro diagnostic medical devices

Include blood glucose monitors, self-tests, companion diagnostics, human genetic testing, immune assays, cancer diagnostic, blood grouping and more.

Technical Team

Orthopedics and dental medical devices

Include orthopedic implants such as soft tissue anchors, hip and knee implants, dental implants and cements and much more.

Technical Team

Active medical devices

Include X-ray machines, OR equipment, surgical robots, software devices, infusion pumps, surgical drills, ventilators and much more.

Technical Team

Medicinal and biologics

Include in vitro fertilization, animal tissue devices, organ preservation, MDR Rule 21, Rule 14 and Article 117 devices and much more.

Technical Team

Microbiology and sterile medical devices

Include sterilization services such as steam, ethylene oxide, and radiation but also aseptic fill, controlled environments and much more.

Our Technical Team

Vascular medical devices

Include heart valves, heart failures devices, structural heart occluders, vascular grafts and stent grafts, catheters, guidewires and much more.

Our Processes

Where are you in the medical device product development lifecycle?

Select the stage that represents where your product is in the product lifecycle to help you identify additional considerations you should look into.

  • Phase 1: Concept
  • Phase 2: Planning
  • Phase 3: Design
  • Phase 4: Validation
  • Phase 5: Launch
  • Phase 6: Post Market
Phase 1: Concept

Initial evaluation of possible development of commercial product

  • Is it a medical device?
  • Intended use
  • Initial risk analysis
  • Product definition and intellectual property
  • Commercial plan
  • Potential markets and routes
  • Draft regulatory strategy
  • Personnel/resource requirements
Phase 2: Planning

Defining design input based on customer needs and technical requirements

  • Concept development
  • Prototype analysis
  • Initial testing
  • Design file and risk analysis
  • User feedback
  • Commercial and market strategy
  • Regulatory strategy
  • Quality management system
  • Project plan
Phase 3: Design

Product design and manufacturing process, verification and validation

  • User feedback 
  • Manufacturing process
  • Design verification and validation
  • Risk management
  • Draft technical documentation
  • Regulatory strategy
  • Product claims and branding
  • Regulatory requirements
Phase 4: Validation

Validation of manufacturing process, preparation for product introduction

  • Market plan/forecast
  • Process validation
  • Clinical validation
  • Product claims
  • Final labelling
  • Regulatory submission
  • Product reimbursement
  • EU CE marking and UKCA marking
  • Global market access certification
Phase 5: Launch

Product launch

  • Regulatory approval
  • Sales and clinician training
  • Launch product to market
  • Individual country reimbursement approval
Phase 6: Post Market

Post market surveillance

  • Post market surveillance
  • Post market clinical follow-up
  • Complaints and adverse events
  • Product improvements
  • Process improvements
  • External body audits
  • Market performance
  • New market launches
Regulatory Services

A range of comprehensive and proven regulatory services

We provide you with efficient pathways to bring your device to market.

Get in touch
Regulatory Services


The European Medical Device Regulation (MDR) replaced the MDD and the AIMDD. Entered into force on 25 May 2017 with 26 May 2021 date of application.

Regulatory Services


The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application.

Regulatory Services

CE marking

CE marking is the medical device manufacturer’s claim that a product meets the General Safety and Performance Requirements (GSPR) of the EU MDR.

Regulatory Services

UKCA marking

UKCA marking is the medical device manufacturer’s claim that a product meets the Essential Requirements (ER) of the UK MDR (2002).

Regulatory Services

ISO 13485 - Quality management system

ISO 13485 is an harmonized and internationally recognized standard for quality management systems (QMS) in the medical device industry.

Regulatory Services

Medical Device Single Audit Program

MDSAP allows a single audit of a medical device manufacturer’s QMS, which satisfies the requirements of multiple regulatory jurisdictions.

Regulatory Services

ISO 14971 Risk management for medical devices

ISO 14971:2019 defines the international requirements of risk management systems for medical devices.

Regulatory Services

EN 60601 Medical electrical equipment and systems

EN 60601 is a group of standards covering the safety and essential performance of medical electrical equipment and related systems.

Regulatory Services

Global market access for medical device manufacturers

We offer medical devices certification services to manufacturers around the globe.

Regulatory Services

Small and Medium Enterprises (SMEs)

We offer a wide range of resources to support SME's by increasing their knowledge on key regulatory topics for market readiness.

Our Role

Role of a Notified Body and UK Approved Body

The role of a Notified Body and of a UK Approved Body is to conduct a Conformity Assessment under the relevant EU Regulations (MDR and IVDR) or UK legislation (UK MDR 2002), respectively.

The Conformity Assessment usually involves an audit of the manufacturer’s quality system (QMS) and, depending upon the device classification, a review of the relevant technical documentation provided by the manufacturer in support of the Safety and Performance Requirements (EU) or Essential Requirements (UK) for the device.

Who We Are

Incorporated by Royal Charter, we are the first UK National Standards Body

BSI Medical Devices is an accredited Certification Body for ISO 13485 in several global markets and a recognized Auditing Organization for the Medical Device Single Audit Program (MDSAP).

BSI The Netherlands (2797) is a leading full-scope Notified Body. BSI UK (0086) is a full-scope UK Approved Body. We review medical devices and IVDs to ensure conformity to the European and UK legislations requirements.


What is outside the scope of a Notified Body and UK Approved Body

We carry out conformity assessments and verification activities with the highest degree of professional integrity and impartiality.

We have no writing or decision-making rights on EU and UK legislation

Our input is considered during the debating stage. We assess against the requirements of the relevant legislation.

We are not allowed to provide consulting services

Regarding design, development, marketing or maintenance of medical devices and IVDs, or processes under assessment.

Insights & Media

A wide range of free and live webinars

Hosted by BSI Technical Specialists addressing key topics that affect your business including legislation, risk, and regulatory changes.

Get Insights & Media
Contact Us

Get in touch

Whether you're starting the certification process, looking to transfer or need to discuss your options, we can guide you through the process.

Get in touch