EU MDR compliance for Legacy Devices

EU MDR compliance for Legacy Devices

Legacy devices are the medical devices, active implantable medical devices and in vitro diagnostic devices that are placed in the market with valid certificates issued from Medical Devices Directive (MDD) or Active Implantable Medical Device (AIMD). The valid CE (Conformité Européenne) marking certificates are issued according to Directive 93/42/EEC, Directive 90/85/EEC or Directive 98/97/EC on medical devices. The legacy devices continue to be in market when it meets EU MDR compliance for legacy devices as per set timelines.REGISTRATION OF LEGACY DEVICES A document “MDCG 2019-5 “Registration of legacy devices in EUDAMED April 2019” explains the guidance on registration of legacy devices in EUDAMED.  EUDAMED is the European Database for Medical Devices.  According to new guidelines the legacy devices are registered in EUDAMED. The registration of legacy devices is mandatory when there is a serious incident related to the product or there is any field corrective action necessary towards it.A NEW GUIDANCE ON EU MDR COMPLIANCE FOR LEGACY MEDICAL DEVICES The European Commission’s Medical Device Coordination Group (MDCG) ‘s has put forth a new guidance that describes the implementation and application of MDR requirements for legacy devices and the devices placed in the market before 26 may 2021. The MDGC had set up ad hoc task- force for applying transitional provisions to the legacy devices and devices placed in the market before 26 may 2021 mentioned in Article 120(3) of Regulation (EU) 2017/745 (MDR)Read More  –   EU MDR compliance for Legacy Devices
Read More Article – 1. Orthopedic Implants Manufacturing2. disposable syringe manufacturers3. Dental Implants Manufacturing4.Blood Collection Tubes ManufacturingContact details –Phone  no –  93702 83428Mail id – enquiry@operonstrategist.com