The Medical Devices Introductory Course 2020

Regulatory Requirements

Conformity Routes All routes: • Compliance with harmonized standards (e.g. EN ISO 14971 and EN ISO 13485) gives a presumption of conformity (see also Annex Z) • Require post-market surveillance appropriate to risk (via Annex X)

“confirmation of conformity ... under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio... must be based on clinical data.”

The Organisation for Professionals in Regulatory Affairs

Risk Management & MDR

• Risk, Risk Management or Benefit-Risk is cited over 240 times within the Regulation(s)

• Risk is defined in Article 2, Definitions as: • the combination of the probability of occurrence of harm and the severity of that harm • Benefit-Risk Determination is defined in Article 2 as: • the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer • Article 10, General Obligations: • Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I The MDR is in alignment with EN ISO 14971:2019 and EN ISO 13485:2016

• The Quality Management Systems shall address: • risk management as set out in in Section 3 of Annex I

The Organisation for Professionals in Regulatory Affairs