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.
Our mission is to ensure patient safety whilst supporting timely market access to medical technology in a sustainable manner
Maintaining quality and delivering excellence
BSI Medical Devices offers certification services to support your global market access goals. We are:
MDR and IVDR Services and Fees
Download our fees for IVDR and MDR Conformity Assessments that are effective from 1 January 2024.
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 technical teams
Active implantable medical devices (AIMD)
Include Pacemakers, defibrillators, neurostimulators systems, cochlear implants, infusion pumps, implantable glucose monitors, MEMs and much more.
Artificial intelligence (AI)
Discover AI application to medical devices and ensure you meet the relevant regulatory requirements to enter this growing market.
General medical devices
Include implantable, wound and skin care, ophtalmic, infusion, transfusion medical devices and much more.
In vitro diagnostic medical devices
Include blood glucose monitors, self-tests, companion diagnostics, human genetic testing, immune assays, cancer diagnostic, blood grouping and more.
Orthopedics and dental medical devices
Include orthopedic implants such as soft tissue anchors, hip and knee implants, dental implants and cements and much more.
Active medical devices
Include X-ray machines, OR equipment, surgical robots, software devices, infusion pumps, surgical drills, ventilators and much more.
Medicinal and biologics
Include in vitro fertilization, animal tissue devices, organ preservation, MDR Rule 21, Rule 14 and Article 117 devices and much more.
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.
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
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
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
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
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
- Regulatory approval
- Sales and clinician training
- Launch product to market
- Individual country reimbursement approval
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
A range of comprehensive and proven regulatory services
We provide you with efficient pathways to bring your device to market.Get in touch
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.
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.
CE marking is the medical device manufacturer’s claim that a product meets the General Safety and Performance Requirements (GSPR) of the EU MDR.
UKCA marking is the medical device manufacturer’s claim that a product meets the Essential Requirements (ER) of the UK MDR (2002).
ISO 13485 - Quality management system
ISO 13485 is an harmonised and internationally recognized standard for quality management systems (QMS) in the medical device industry.
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.
ISO 14971 Risk management for medical devices
ISO 14971:2019 defines the international requirements of risk management systems for medical devices.
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.
Role of a Notified Body and UK Approved Body
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.
Incorporated by Royal Charter, we are the first UK National Standards Body
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.
A range of comprehensive and proven resources
We provide you with efficient pathways to bring your device to market.
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.