Who it’s for
Who should attend
Regulatory affairs and quality staff, Persons Responsible for Regulatory Compliance and their deputies, product and project managers, importers, distributors and authorised representatives, and senior management of legal manufacturers.
Curriculum
Course modules
- Structure of the MDR: chapters, articles and annexes; scope and definitions
- Economic operators: manufacturer, authorised representative, importer, distributor; Article 16 obligations
- Article 15: Person Responsible for Regulatory Compliance
- Classification: Annex VIII rules
- General Safety and Performance Requirements: Annex I and the GSPR checklist
- Technical documentation: Annexes II and III
- Conformity assessment routes: Annexes IX, X and XI; notified body involvement
- Clinical evaluation: Article 61 and Annex XIV; clinical investigations
- UDI, EUDAMED and registration obligations
- Post-market surveillance: Chapter VII, PMS plan, PMS report, PSUR, PMCF
- Vigilance, serious incidents, FSCA and trend reporting
- Declaration of conformity, CE marking, and the role of MDCG guidance
Outcomes
What you’ll be able to do
- Navigate the MDR and locate the applicable requirement
- Classify a device and select the correct conformity assessment route
- Understand what a notified body will expect to see
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Medical Devices Regulation”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.