IPN - Instituto Pedro Nunes - IPN promotes training on European Regulation EU 2017/745 on Medical Devices

Clique aqui para a versão em português. 

Between 11 November and 4 December 2025, Instituto Pedro Nunes (IPN) will be running a training course on the European Regulation EU 2017/745 on Medical Devices, an initiative aimed at professionals in the medical device industry who want to understand European regulatory requirements and ensure their products are compliant.

With a total duration of 28 hours, in online format, this training course offers a practical and in-depth overview of the main regulatory steps that a medical device must comply with in order to obtain the CE marking, addressing topics such as the qualification and classification of devices, the preparation of technical documentation and the application of general safety and performance requirements.

Aimed at professionals in Regulatory Affairs, Quality, R&D, Engineering, consultants and recent graduates who wish to specialise in the area, this course combines synchronous sessions with independent study via the Moodle platform, promoting dynamic and flexible learning.

What you will learn:

• Explain the application and scope of the MDR (Regulation (EU) 2017/745).
• Describe the milestones for obtaining the CE mark.
• Classify and qualify devices according to MDR criteria.
• Identify the roles and responsibilities of all stakeholders (Manufacturer, Distributor, Importer, Authorised Representative, Person Responsible for Regulatory Compliance - PRRC, Notified Body, Competent Authority).
• Navigate and explain the main elements of EUDAMED and UDI.
• Apply the requirements of Annex I (General Safety and Performance Requirement - GSPR), Annexes II & III (Technical Documentation - TD), Article 10 (Quality Management System - QMS) and link to ISO 13485.
• Assess pre-clinical, clinical and usability evaluation requirements.
• Identify the Information Provided by the Manufacturer (Instructions for use, labels, among others).

The training will be led by a multidisciplinary team of experts from the Medical Devices Regulatory Support unit (MDRu) of IPN with extensive experience in the areas of regulation, quality and clinical evaluation of medical devices, namely Inês Urbano, Francisco Teixeira, Raquel Gomes, Carla Santos, Anabela Pinto, and Sílvia Antunes.

As a complementary action, IPN is also promoting a free webinar entitled “Demystifying the MDR: Key Steps to Regulatory Compliance”, with Ana Brito, coordinator of IPN’s Medical Devices Regulatory Support Unit, on 29 October at 5pm. Sign up here.

Registration is open until 7 November 2025 here, with a 15% discount for companies incubated at IPN and 10% for more than one registration for the same company. Until 27 October, registration can be made for EUR 323 + VAT, rising to EUR 380 + VAT after that date (non-cumulative discounts).  This training will be held in portuguese.

IPN is a DGERT-certified entity, ensuring that, at the end of the course, participants will receive a professional training certificate.

For more information, please consult the PDF with the complete training programme.