The Medical Devices Introductory Course 2020

GSPR Checklist Requirement

Basis for claiming compliance with GSPRs: Standards complied with or justification for non- compliance; test results; reference to relevant Reports:

A/NA Relevant

Standards:

A N/A

(ref.; date; clauses)

Documentation/Procedure/Report

Location

GSPR 1. Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.

GSPR2. The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the risk-benefit ratio..

GSPR3. Manufacturers shall establish, implement, document and maintain a risk management system.

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The Organisation for Professionals in Regulatory Affairs

Harmonised Standards Article 8.1 (MDD Article 5)

“Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. ”

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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