The conformity assessment procedures for complete/full quality systems, which include design controls, in Annex 2 of the Active Implantable Medical Devices Directive (90/385/EEC) and Annex II of the Medical Devices Directive (93/42/EEC), require that the application to Notified Bodies for the evaluation of the quality system includes a description of the procedures for clinical evaluation. This means that standard operating procedures (SOPs) for clinical evaluation must be developed. The need for Notified Bodies to assess the manufacturer’s procedure for clinical evaluation is also included in the EU guidance, “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC” (MEDDEV 2.7/1 Rev 4).
Article 10 of the Medical Devices Regulation (MDR; EU 2017/745) requires that all manufacturers establish a quality management system. Paragraph 9, point (f) requires that this system address clinical evaluation. It is expected that the way that most companies will address clinical evaluation will be to develop a standard operating procedure (SOP).
Where manufacturers select MDR Annex IX, ‘Conformity Assessment Based on a Quality Management System and on Assessment of Technical Documentation’, as a conformity assessment procedure for CE marking purposes, Section 2.2 (c) of the Annex requires that design-related procedures specifically cover clinical evaluation. It is anticipated that most manufacturers will select Annex IX as the preferred conformity assessment procedure.
DLC can help you to:
Evaluate existing CER SOPs to determine their adequacy in meeting MDR requirements
Develop CER SOPs that will meet current requirements under the medical devices directives
Develop CER SOPs or revise existing CER SOPs in order to meet MDR requirements
DLC has the knowledge and experience to assist you in the development of effective medical device, IVD and combination product regulatory, clinical study, and quality system strategies, so that important project milestones within planned timelines can be met. Contact us either by e-mail for a confidential discussion about your project, or call Dr. Maria Donawa, President, on +39 06 578 2665.