Since entry into force of the Medical Device Regulations (MDR – Regulation EU 2017/745 & IVDR – Regulation EU 2017/746) on May 26th, 2017, medical device manufacturers are working hard on establishing evidence for compliance of their legacy devices with the new set of rules. In fact, neither the MDR nor the IVDR provide for “Grandfathering” of legacy devices. In other words, any device on the market will have to undergo conformity assessment under the new ruling latest by May 2024.
For the development of new devices, most manufacturers have already shifted from the regulatory framework of the directives to the new one of the regulations. Understanding of the transition provisions is key to determine the strategic options and set up a roadmap tailored for the individual need of a medical device manufacturer.
For establishing a strategy for transition for legacy devices, manufacturers should do more than working on the clinical data set through their Post Market Surveillance program. Please find additional information in this white paper published in collaboration with BSI.
Medidee helps to determine an effective strategy to transit to the new ruling. We have the expertise and resources for assessing your V&V evidence against the General Requirements for Safety and Performance (GRSP – Annex I of the Regulations) and assists you with subsequent updates required throughout the technical documentation. Our scientific team is ready to support your clinical departments with scientific and medical writing to get your Clinical Evaluations up to date, from determining a PMS plan to the writing of Clinical Investigation Reports as a result of PMCF studies.
Medidee’s Regulatory and Quality Assurance team is adapting quality systems to the requirements of the regulations on a daily basis. Take advantage of the established routine to get ready for Annexes IX, X or XI for your conformity assessment under the regulations.