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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 support your global market access goals. 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

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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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.

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.

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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.

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