Change control — Mastering product changes in Europe and internationally
Every product change engages the manufacturer's regulatory responsibility. Do you know exactly when to notify your notified body, how to assess the impact of a change on your technical documentation, and which procedures to trigger market by market? This one-day training course gives RA, QA and R&D teams a concrete method to govern the change control process, from the initial impact analysis through to documentary closure, in compliance with the MDR 2017/745, ISO 13485 and the main international regulations.
Audience Regulatory affairs managers and officers, quality managers, R&D engineers involved in product change management, within medical device manufacturers operating in European and/or international markets.
Learning objectives
- ▸ Distinguish between substantial and non-substantial changes within the meaning of the MDR 2017/745 and the applicable MDCG guidance, and justify this qualification in the file
- ▸ Apply the framework for analysing the impact of a change on the GSPR, the technical documentation, the clinical evaluation and the QMS, in connection with ISO 14971
- ▸ Identify the triggers for notification to the notified body, the associated regulatory deadlines and the procedures for updating CE certificates
- ▸ Map the change control requirements of the main international regulations (21 CFR Part 820, SOR/98-282, ANVISA, PMDA, TGA) and build an action plan differentiated by market
- ▸ Draft a change control procedure and the associated records (request form, impact matrix, traceability of decisions) compliant with ISO 13485 §§ 4.1.6 and 7.3.9
- ▸ Coordinate the closure of a change control: updating the documentation system, communicating to internal and external stakeholders, updating EUDAMED if applicable
Expected outcomes
- ✓ On completion of the training, each participant is able to autonomously conduct the analysis of a product change, qualify its substantial nature, manage the associated regulatory actions and compile the corresponding traceability file.
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 the ISO 13485 quality management system and fundamental notions of the MDR 2017/745 recommended. Suggested level: professional working in an RA, QA or R&D function within a medical device manufacturer.
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 fundable via the OPCO
- ·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 framework of change control (1 h)
- ·Definitions: what is a change, what is a modification?
- ·Reference texts: MDR 2017/745 (Annexes IX and XI), ISO 13485 §§ 4.1.6 and 7.3.9, relevant MDCG guidance, NBOG BPG
- ·Overview of the main international standards: FDA 21 CFR Part 820, ICH Q10 (combination devices), Canadian, Brazilian, Japanese and Australian regulations
- 02
Change qualification and impact analysis (2 h)
- ·Substantial vs non-substantial change: qualification criteria, documented decision tree
- ·Impact analysis on the GSPR (MDR Annex I), the technical documentation (Annexes II and III), the clinical evaluation, risk management (ISO 14971) and the QMS
- ·Practical qualification cases: design, materials, subcontracting manufacturer, labelling, embedded software
- 03
Change control process: steps and governance (2 h)
- ·Process steps: triggering, impact analysis, decision, action plan, implementation, verification, closure
- ·Articulation with the CAPA, design and development, and document control processes
- ·Roles and responsibilities: change committee, PRRC, RA Manager
- ·Regulatory action plan according to market: notified body notification, certification update, EUDAMED update
- 04
Change control documentation and procedure (1 h 30)
- ·Structure of a change control procedure compliant with ISO 13485
- ·Change request form, impact matrix, decision register
- ·Revision of the documentation system following the change: which documents to review, in what order, with what evidence of approval
- ·Template for international action plans (tracking table by territory)
- 05
Stakeholder communication and closure (30 min)
- ·Informing customers, distributors and competent authorities according to the requirements of each market
- ·Updating EUDAMED: when and how
- ·Formal closure of the change control and archiving
- ·Lessons learned and field best practices
Assessment of learning
Assessment methods
QCM of 15 to 20 questions at the end of the day covering the key points of the programme (change qualification, notification triggers, documentary obligations). Results are communicated at the end of the session.
Certificate
Training certificate issued by ISOFAC Group at the end of the day, subject to full participation in the session. This certificate does not constitute a certification recognised by the RNCP or the Répertoire Spécifique (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
- ·Training slides in PDF format
- ·Change control document templates: request form, impact matrix, international tracking table
- ·"Substantial / non-substantial qualification" decision tree under MDR
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.
Open-enrolment capacity
6 to 12 participants maximum, to encourage exchanges and the customisation of practical cases.
Funding
- ·This training is not Qualiopi-certified and is not fundable via the OPCO
- ·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.