ECM organises an 8-hour training course to get a better understanding of the clinical evaluation process of medical devices in relation to the requirements of Regulation 2017/745 (MDR).

On 26 May 2021, the new European Regulation for Medical Devices will become applicable, introducing many new issues for manufacturers and all actors involved in the certification process.

Clinical Evaluation – i.e. that “systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer” (Art.2 point 44, Regulation (EU) 2017/745) – becomes one of the key documents of the new regulation.

To navigate through the complexity of the new requirements, ECM Academy proposes an 8-hour online training course on 8 and 15 June.

WHO IS THE COURSE FOR?

Experts in regulatory affairs, professionals in charge as Person Responsible for Regolatory Compliance (PRRC), physicians, quality and clinical experts, designers and engineers in the medical sector.

AIMS OF THE COURSE

The course aims to provide participants with the essential knowledge to deal with the clinical evaluation process in all its aspects, identifying the key requirements of the new regulation, the steps and principles of the clinical evaluation process, how to apply and report them. MDCG guidance documents and other relevant guidelines will also be discussed in order to provide participants with a practical tool to address the new requirements.

TOPICS COVERED

• Requirements on clinical evaluation, from Directive 92/42/EEC to Regulation (EU) 2017/745
• Requirements and contents of MEDDEV 2.7.1 rev.04
• Requirements and contents of MEDDEV 2.12-2 on PMCF
• Documentation for clinical evaluation: drafting and updating
• Links with the requirements of EN ISO 13485:2016
• Post-Marketing Surveillance and Vigilance.

USEFUL INFO

When:

• Tuesday 8 June 2021 in English
• Tuesday 15 June 2021 in Italian

Where: online by remote

Info and costs: Antonio Balassone – Sales Manager ECM – antonio@entecerma.it | tel. (+39) 393 2471040

Ente Certificazione Macchine – Notified Body no.1282, Accredited Testing Laboratory no.1515L and Authorised Training Body no.6737 – boasts a team of highly qualified experts with internationally proven experience and expertise. Our Training Courses are designed to offer a highly professional learning experience, aimed to provide participants with in-depth knowledge of the topic covered.