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

• Main Authors: Ivanovska Elena, Tonić-Ribarska Jasmina, Lazova Jelena, Popstefanova Nada, Davcheva-Jovanoska Marija, Trajković-Jolevska Suzana
• Format: Article
• Language: srp
• Published: Pharmaceutical Association of Serbia, Belgrade, Serbia 2019-01-01
• Series: Arhiv za farmaciju
• Subjects: medical device regulation 2017/745 (mdr); clinical evaluation; post-market surveillance (pms); clinical investigation (ci); post-market clinical follow-up (pmcf)
• Online Access: https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2019/0004-19631901039I.pdf
• ISSN: 0004-1963; 2217-8767

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.