The Medical Devices Introductory Course 2020

Example: Software Annex I.17.2

“… software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation” • Demonstrate compliance with the ERs and GSPRs by compliance with the Harmonised Standards – EN 62304:2006 Medical device software - Software life-cycle processes – EN ISO 14971:2012 Medical devices - Application of risk management to medical devices • Hint: Enter standard(s) and report number(s) in checklist. Include summary, reports and evidence of compliance in the Technical Documentation.

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

33

Common Specifications Article 9 – New

“1. ... where no harmonised standards exist or where relevant harmonised standards are not sufficient, the Commission … may adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III … 2. Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or parts thereof. 3. Manufacturers shall comply with the CS unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent …”

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

34