Auditing under the requirements of MDR 2017/745 — Mastering the regulatory specificities that change everything
You already audit. You know ISO 13485. But MDR 2017/745 has reconfigured the scope of your audits: new annexes, expanded responsibilities of economic operators, reinforced requirements on post-market surveillance, revisited classification. This training gives you the keys to transform your audit plans and findings into concrete responses to the requirements of the European Regulation.
Audience Experienced internal auditors, regulatory affairs (RA) managers and officers, quality managers wishing to deepen their reading of the MDR in an audit context.
Learning objectives
- ▸ Distinguish the substantive requirements of MDR 2017/745 from ISO 13485 requirements and identify their areas of overlap and divergence in an audit plan.
- ▸ Analyse Annexes I (GSPR), IX, X and XI of the MDR in order to derive the applicable audit criteria according to the class and conformity route of the device.
- ▸ Assess the compliance of a quality system with MDR obligations relating to economic operators (manufacturer, authorised representative, importer, distributor) and to the PRRC (Article 15).
- ▸ Build an audit plan integrating the specific MDR requirements: UDI, EUDAMED, PMS, vigilance, clinical evaluation.
- ▸ Formulate regulatorily grounded non-conformities and observations, referenced to the articles and annexes of the MDR.
- ▸ Adapt your audit methodology to the different device classifications (class I, IIa, IIb, III) and to the associated conformity assessment procedures.
Expected outcomes
- ✓ Annual audit programme revised in light of the MDR.
- ✓ Ability to conduct an internal or supplier audit integrating the specific MDR regulatory aspects.
- ✓ Production of an audit report referenced to the texts (articles, annexes, MDCG Guidance).
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
Proven experience in quality auditing (internal or supplier) in the medical device sector. Operational knowledge of the ISO 13485:2016 standard required. A basic knowledge of MDR 2017/745 is recommended.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
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 architecture of the MDR: reading for the auditor (2h)
- ·Review of the scope of application and key definitions
- ·Structure of the regulation and mapping of the annexes
- ·Articulation MDR / ISO 13485 / MDCG Guidance
- ·What the MDR requires beyond the standard
- 02
General safety and performance requirements — Annex I GSPR (2h)
- ·Critical reading of Annex I as an audit grid
- ·Link between GSPR and technical documentation
- ·Priority control points according to the device class
- ·Practical cases of formulating audit findings referenced to Annex I
- 03
Classification, conformity routes and implications for the auditor (2h)
- ·New MDR classification criteria (rules 1 to 22)
- ·Conformity assessment procedures by class (Annexes IX, X, XI)
- ·Auditing a documentary system according to the chosen conformity route
- ·Role of the notified body: what the internal auditor must anticipate
- 04
Economic operators, PRRC and auditable responsibilities (1h30)
- ·Obligations of the manufacturer, authorised representative, importer, distributor (Articles 10 to 14)
- ·PRRC (Article 15): requirements, designation, auditability
- ·Lines of questioning and verification during an audit
- 05
UDI, EUDAMED and traceability: audit controls (1h)
- ·Unique device identification system (UDI): marking and registration requirements
- ·EUDAMED: reporting obligations and verification of their implementation
- ·Documentary and system control points
- 06
Post-market surveillance, vigilance and clinical evaluation (2h)
- ·PMS plan and periodic safety report (PSUR / SSCP)
- ·Vigilance: triggers, deadlines, expected records
- ·Clinical evaluation and clinical investigation: what the auditor checks
- ·Cross-audit exercise on technical files adapted to the participants' sector
- 07
Synthesis workshop: simulating an MDR audit (1h30)
- ·Collective construction of an MDR audit plan on a practical case
- ·Formulation and calibration of non-conformities
- ·Debriefing and feedback from the trainer
Assessment of learning
Assessment methods
Final QCM of 20 questions covering all the modules · role-play scenario: formulation of 2 non-conformities based on an extract from a fictitious audit file, with commented correction by the trainer. Training certificate issued by ISOFACADEMY subject to full participation in both days. This certificate does not constitute an RNCP/RS certification; it attests to participation and to the acquisition of the content delivered.
Certificate
A certificate of completion is issued to each participant, detailing the objectives, duration, learning assessed and the result of the final assessment. The document can be kept in a skills record.
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)
1 590 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Personalised quote and OPCO funding application prepared 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.