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.

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Maintaining quality and delivering excellence

BSI Medical Devices offers certification services to place safe and compliant medical devices on the market. We are:

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 2025.

MDR Services & Fees IVDR Services & Fees

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.

Certification policy

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.

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Technical Team

Artificial intelligence (AI)

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

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Technical Team

General medical devices

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

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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.

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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.

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Technical Team

Active medical devices

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

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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.

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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.

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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.

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Technical Team

Software as a Medical Device

Infusion pump software, picture archiving and communication software, image processing software, standalone software, apps for phones and much more.

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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

Technologies

Compliance navigator

A unique platform designed to monitor your compliance against over 6,000 essential documents regulating medical devices, IVDs, QMS and other topics.

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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.

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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.

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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.

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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).

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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.

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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.

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Regulatory Services

ISO 14971 Risk management for medical devices

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

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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.

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Regulatory Services

Global market access for medical device manufacturers

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

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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.

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Regulatory Services

Structured Dialogue

An opportunity to understand and enhance the efficiency and predictability of the conformity journey for medical devices and IVDs.

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Regulatory Services

Article 16(4) Certification

Applies to importers and distributors engaging in relabeling and repackaging activities subject to Article 16(2).

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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.

Resources

A range of comprehensive and proven resources

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

Resources

Our excellence pathways

Discover our experienced and efficient routes to place compliant and safe devices on global markets.

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Resources

Medical Devices Regulatory Services portfolio

Discover how we can support your compliance journey through our regulatory services portfolio.

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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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