Under the Medical Devices Regulation (MDR, EU 2017/745), all manufacturers are required to establish and maintain a quality management system (QMS) (Article 10). Paragraph 9, point (f) specifically requires that the QMS address clinical evaluation. Most manufacturers meet this requirement by developing a standard operating procedure (SOP) for clinical evaluation.
Where manufacturers select Annex IX, Conformity Assessment Based on a Quality Management System and on Assessment of Technical Documentation, as their conformity assessment route for CE marking, Section 2.2(c) requires that design-related procedures specifically cover clinical evaluation. Annex IX is anticipated to be the most commonly selected conformity assessment procedure.
This requirement reflects the expectation that manufacturers have documented and systematic processes in place for planning, conducting, and documenting clinical evaluations in compliance with MDR requirements, as described in Annex XIV, Part A of the Regulation and related EU guidance documents.
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 MDR
- Revise existing CER SOPs in order to meet MDR requirements
