Providing clinical evidence under the MDR 2017/745 – new challenges for manufacturers in medical device industry

Abstract

Providing necessary clinical evidence throughout the systems for Clinical Evaluation and Post-Market Surveillance in accordance with new MDR 2017/745 requirements imposes new challenges for manufacturers in medical device industry. Manufacturers should make clinical evaluation a continuous process that summarizes findings and results from several mutually connected processes: PMS, vigilance, CIs. Gathered clinical evidence should also be used as input for SSCP, PSUR, CEAR. CIs should be designed, authorised, conducted, recorded and reported in accordance with provisions of Articles 62-81 and Annex XV. PMS and PMCF activities should provide appropriate evidence of planning, implementation of protocol and reporting; target residual risks and confirm safety and performance over device’s lifetime; include activities that address specific questions/residual risks. All activities are aimed towards several goals: improving quality, safety and reliability of devices and strengthening transparency of information for consumers.