Medical Device Regulatory Affairs

  • 1° EDITION: October 1stand 2nd 2024
  • 2° EDITION: February 18th and 19th 2025
  • Online
  • Italian

Training overview

During the training course “Medical Device Regulatory Affairs”, key issues for those who want to operate or work in this field will be addressed in light of the changes introduced by the current Medical Devices Regulation (MDR 745/2017). Based on the lecturer’s long experience in the field of medical devices, the new obligations of the various economic actors, the new UDI traceability system and the preparation of technical documentation based on the requirements of Reg. 745/2017 will be examined.

The Medical Device Regulatory Affairs training course will explain the current regulations and provide you with the tools you need to better manage the process of obtaining CE marking for a new medical device and for managing the entire regulatory life cycle of the medical device.

Are you interested in Medical Device training?

Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
Choose among these titles:

(*) discounts apply to the full prices of the courses and cannot be combined with other promotions.
The promotion is limited to enrolling the same person in 3 or 5 courses selected from those offered.

Key points of the training

  • Understand the main requirements on European medical device regulation and the changes brought about by MDR 745/2017
  • Provide the basic information for developing and drafting the technical documentation required to obtain CE marking for a new device
  • Give you the tools to ensure regulatory compliance of your medical device throughout its journey

09:00 – 13:00   COURSE SESSION – MODULE 1
09:00 – 13:00   COURSE SESSION – MODULE 2



  • Regulatory framework: Directive 93/42 vs. Regulation 745/2017
  • Main changes introduced by Reg. 745/2017 and implementation timeline
  • Medical devices: definitions and regulatory approach
  • Roles and new responsibilities of economic operators
  • The figure of the Person Responsible for compliance
  • Classification of Medical Devices: updates introduced by Reg. 745/2017


  • EC conformity: notified bodies, EC certification, declaration of conformity
  • The technical documentation: annexes II and III of Reg. 745/2017
  • The new UDI traceability system
  • The medical device vigilance system
  • The national database and the European database for Medical Devices (EUDAMED)

Regulatory Affairs, Quality Assurance, management personnel, research and development managers, production managers, process managers, managers/coordinators, complaint management and corrective and preventive actions, supervisory managers, marketing/sales managers.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.


Patrizia Pecin

Patrizia Pecin

Regulatory Affairs Project Manager at Pharma D&S

Graduated in 1991 in Biological Sciences at the University of Milan, she later obtained a II level Master’s Degree in Regulatory Disciplines at the University of Pavia. She has gained professional experience in the regulatory field in pharmaceutical companies and since 2005 her activity has been focused on the medical devices sector. Currently in Pharma D&S she deals with regulatory issues relating to Medical Devices; she also deals with training activities within the Pharma Education Center.

Register now

Early Bird 10%
Within 2 months before the start of the training
Early Bird 5%
Within 1 month before the start of the training
Full price


Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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