A foundation course designed to walk the participants through the key elements and main changes in the Medical Device Regulation EU 2017/745 compared to the Medical Device Directive.

Objectives

• Understand the intent of the MDR and its requirements;
• Identify the key changes compared to the MDD;
• Define the scope of the regulation and its impact;
• Learn on the interpretation of the new requirements.

Pre-requisites

Participants must have complete knowledge of the MDD (medical device regulation); the relevant harmonized standards and common specifications; and the MEDDEVs – the guidance documents written by the Competent Authorities.

Audience

Auditors, consultants, healthcare professionals, people responsible for regulatory compliance, quality management, clinical evaluation or risk management related to medical devices.