Providing clinical evidence under the MDR 2017/745 – new challenges for manufacturers in medical device industry
Journal
Arhiv za farmaciju
Date Issued
2019
Author(s)
Ivanovska E., Tonic Ribarska J., Lazova J., Popstefanova N., Davcheva Jovanoska M., Trajkovic Jolevska S.
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.
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.
Subjects