Biocompatibility and biological evaluation of medical devices — Demonstration of conformity according to ISO 10993
Notified bodies expect a structured biological evaluation file that is well-argued and consistent with risk management. This training gives R&D, regulatory affairs and quality teams the methodological tools to design a rigorous biological evaluation plan, select the appropriate tests and draft the elements required in the MDR technical documentation.
Audience R&D engineers, regulatory affairs officers, quality managers and anyone involved in demonstrating the biological safety of medical devices.
Learning objectives
- ▸ Position the ISO 10993-1:2025 requirements within the MDR 2017/745 regulatory framework and identify the links with Annex I (GSPR) and ISO 14971
- ▸ Build a complete biological evaluation plan based on the contact category and exposure duration of the device
- ▸ Select the relevant biological and chemical tests, justifying the choices through a documented risk analysis
- ▸ Conduct a chemical characterization of materials according to ISO 10993-18 and interpret the results within a toxicological risk estimation approach (ISO 10993-17)
- ▸ Draft or revise a biological evaluation report compliant with the expectations of notified bodies
- ▸ Integrate post-production data and vigilance information into the periodic reassessment of biocompatibility
Expected outcomes
- ✓ A standard biological evaluation plan that is directly applicable
- ✓ A test selection matrix
- ✓ A ready-to-use biological evaluation report template for use in the work setting
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
Basic knowledge of medical device regulation (MDR 2017/745) and general notions about the biocompatibility of health products. The IA-REG-01 training (MDR Fundamentals) or an equivalent level is recommended beforehand.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·This training is not Qualiopi-certified and is not eligible for funding through the OPCOs
- ·Funding from own funds or the company's training budget
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Regulatory and normative framework (2 h)
- ·Relationship between ISO 10993-1:2025 and the requirements of MDR 2017/745 (GSPR Annex I, section 10)
- ·Links with ISO 14971 (risk management) and the other standards of the ISO 10993 series
- ·2025 update: key changes compared to the 2018 version and impacts on existing files
- 02
General principles of biological evaluation (2 h)
- ·Classification of devices by nature and duration of contact
- ·Required input data
- ·Decision-making process: available data, data to be generated, material equivalence
- ·Principles of the 3Rs (reduction of in vivo testing)
- 03
Building the biological evaluation plan (3 h)
- ·Identification of the relevant biological endpoints according to Annex A of ISO 10993-1
- ·Justification of selected tests and excluded tests
- ·Definition of product families and selection of the representative product
- ·Practical exercise: building an evaluation plan from a real-life case
- 04
Chemical characterization and toxicological evaluation (3 h)
- ·Principles of chemical characterization according to ISO 10993-18: extraction, analysis of extractable and leachable substances
- ·Assessment of permissible limits according to ISO 10993-17
- ·Interpretation of chemical risk data
- ·Practical exercise: critical reading of a characterization report
- 05
Drafting and defending the biological evaluation report (2 h)
- ·Structure of the biological evaluation report according to GMED/NB expectations
- ·Scientific literature review: methodology and traceability
- ·Conditions for reassessment and updating of the file
- 06
Integration into the MDR technical documentation and post-production follow-up (2 h)
- ·Positioning of the report within the technical documentation (TD)
- ·Links with post-market surveillance (PMS), vigilance and PMCF
- ·Synthesis exercise: revision of an excerpt from a biological evaluation file
Assessment of learning
Assessment methods
End-of-training QCM (20 questions) covering the principles of the ISO 10993 series, the logic of building the evaluation plan and the MDR regulatory criteria. The practical exercises carried out during the training are an integral part of the assessment of learning outcomes.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full attendance of both days. This certificate does not constitute a certification recognized in the RNCP or the Specific Directory (RS).
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
1 490 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·This training is not Qualiopi-certified and is not eligible for funding through the OPCOs
- ·Funding from own funds or the company's training budget
Personalised quote within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.