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    Capabilities

    Medical Devices

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

    Our Mission

    Our mission is to ensure patient safety whilst 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 place safe and compliant medical devices on the market. We are:

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      A leading full scope Notified Body (2797).

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      A leading full scope UK Approved Body (0086).

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      An accredited ISO 13485 Certification Body.

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

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

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

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    Services & Fees

    MDR and IVDR Services and Fees

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

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    Policy

    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.

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    Regulatory Services

    MDR

    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

    IVDR

    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 harmonised 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

    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.

    Resources

    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.

    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