Medical devices of animal origin — Mastering regulatory requirements and building a robust file
Medical devices incorporating tissues or derivatives of animal origin (MDAO) are subject to a layered, demanding regulatory framework that is poorly covered in training: MDR 2017/745, Regulation (EU) 722/2012, the ISO 22442 series, biological risk management according to ISO 14971. For Regulatory Affairs and R&D teams, mastering this body of texts and knowing how to translate it into compliant technical documentation is a critical challenge — whether the product is under development, in regulatory transition or being maintained on the market.
Audience Regulatory affairs managers and officers, R&D engineers involved in the design or placing on the market of MDAO, quality managers dealing with suppliers of materials of animal origin.
Learning objectives
- ▸ Identify the regulatory scope applicable to MDAO (MDR 2017/745, Regulation (EU) 722/2012, repealed directives) and position the manufacturer's obligations within this framework
- ▸ Apply the requirements of the ISO 22442 series (parts 1, 2 and 3) to biological risk management and to the validation of viral and TSE elimination/inactivation processes
- ▸ Structure the MDAO-specific sections in the technical documentation (GSPR Annex I, risk analysis, traceability of the animal supply chain)
- ▸ Assess the requirements applicable to the selection, qualification and control of suppliers of materials of animal origin
- ▸ Build a compliance or market-maintenance action plan for an existing or in-development MDAO
Expected outcomes
- ✓ A mapping of the applicable texts
- ✓ A biological risk analysis grid adaptable to your product
- ✓ A ready-to-use MDAO compliance plan template
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
General knowledge of the regulatory framework for medical devices (MDR 2017/745). Experience in regulatory affairs or R&D in the MD sector is recommended. The IA-REG-01 training (MDR Fundamentals) may be taken beforehand as preparation.
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 OPCO funding
- ·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 mapping of MDAO (1 h 30)
- ·Definition and scope of MDAO within the meaning of MDR 2017/745
- ·Interplay with Regulation (EU) 722/2012 and the repealed Directive 2003/32/EC
- ·Animal species concerned and TSE risk levels
- ·Role of the competent authorities and the notified body in the assessment of MDAO (MDR Rule 18)
- ·Points of vigilance in a regulatory transition situation
- 02
Normative requirements: ISO 22442 series and ISO 14971 interface (2 h)
- ·ISO 22442-1: management of risks specific to non-viable animal tissues
- ·ISO 22442-2: controls on the sourcing, collection and processing
- ·ISO 22442-3: validation of the elimination and inactivation of viruses and TSE agents
- ·Interface with ISO 14971 for integration into the overall risk management file
- ·Exercise: analysis of an excerpt from an MDAO risk file
- 03
Building MDAO technical documentation (2 h)
- ·General safety and performance requirements (GSPR Annex I) specific to MDAO
- ·Traceability of the animal supply chain: what evidence to document
- ·Critical sections of the technical file: justification of the material choice, characterization data, qualification of the processing methods
- ·Case study: review of a partial technical file, identification of gaps
- 04
Supplier qualification and control of the upstream chain (1 h)
- ·MDR requirements applicable to suppliers of materials of animal origin
- ·Supplier selection and evaluation criteria
- ·Expected content in supplier quality agreements (SQA) for an MDAO
- ·Management of changes in geographic origin or process
- 05
Action plan and compliance (30 min)
- ·Building a prioritized action plan for an MDAO under development or being maintained on the market
- ·Wrap-up and questions / answers
Assessment of learning
Assessment methods
End-of-day QCM (15 to 20 questions) covering the key regulatory and normative points addressed, carried out on the virtual classroom platform. Results are communicated individually at the end of the session.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full attendance of the day. 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.
Materials provided
- ·Annotated slide deck in PDF format
- ·MDAO biological risk analysis grid
- ·MDAO compliance plan template
- ·Mapping of the applicable regulatory and normative texts
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)
790 €
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 OPCO funding
- ·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.