Course Details
Scheduled Events: June 2026
Learning Mode: Online
Language: English
(see more details below)
Learning Objectives
The European regulations on medical devices and in vitro diagnostic devices—known respectively as the MDR (EU Regulation 2017/745) and the IVDR (EU Regulation 2017/746)—require Notified Bodies to regularly carry out unannounced inspections at the premises of organizations holding a CE certificate.
MDR Annex IX 3.4 / IVDR Annex IX 3.4 (Annex XI Chapter 7 / Annex XI Chapter 4)
Unannounced audits by the Notified Body:
The Notified Body shall, at least once every five years, carry out unannounced and random audits at the manufacturer’s premises and, where appropriate, at those of its suppliers and/or subcontractors. […]
The Notified Body shall draw up a plan for such unannounced on-site audits, but shall not disclose it to the manufacturer.
This course provides an overview of the regulatory framework, the legal context, and the requirements set out in the EU Regulations regarding unannounced audits, along with general examples of practical implementation.
Who should attend?
The course is intended for Quality Assurance, Regulatory Affairs, and PRRC managers and team members, as well as all responsible personnel involved in unannounced audits.
Course Agenda
- Regulatory Requirements of MDR (EU Regulation 2017/745) and IVDR (EU Regulation 2017/746)
- Purpose and Frequency of Unannounced Audits
- Areas, Processes, and Activities Subject to Unannounced Audits
- Conducting an Unannounced Audit and Possible Outcomes
- Practical Exercises on Common and General Case Studies
- A Final Exam (optional) is scheduled at the end of the course.
Prerequisites
None.
Course Materials
- Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
- Notebook for didactic use (where applicable), containing a copy of the standards necessary for the training course, to be returned at the end of the course. In order to respect copyright, all the standards of online courses can be provided for consultation only through access to a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is advisable that participants purchase the reference standard directly from the official ISO store https://www.iso.org/home.html or request a copy within their own organisation.
Learning Assessments
- Certificate of competence, in case of successful completion of final exam
- Certificate of attendance, in case of non successful completion of final exam or no exam.
Duration
4 hours.
Scheduled Events
- 16 June 2026, 09:00 am - 01:00 pm (CEST).
Price
490,00 € (per participant, taxation excl.).
Learning Mode
Online, Instructor-Led
Language
Training in English Language
