Since decades, regulation of the medical device industry in Europe has been rather unchanged. However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry. The new Medical Device Regulation adopted by EU, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive.
To meet the new EU Medical Device Regulation objective, organizations will need to take a structured and well-managed approach over the next coming years depending on the product portfolio.
Regulatory strategyBuilding up an ideal Regulatory strategy depending on the device for you to effectively get a handle on EU MDR aspects including Technical, Quality, Clinical, Post-Marketing, Labeling, Economic Operators and other areas
GAP AnalysisMakroCare reviews Tech files & data to find the gaps in EU MDR compliance and provide a remediation plan to address those gaps
Clinical EvidenceFull service clinical evidence programs from advisory to implementation involving Retrospective/ EMR data, Surveys, Literature and setup of Registries. Review your device data, determine usability & final report generation
Post Market Support ActivitiesSupport PMS along with PMCF formalizing a plan for aggregate reports by process creation to standardization of templates/SOPs. Also Support in PSUR, SSCP and annual updates
UDI SetupMakroCare advice in setting up UDI program along with required software
Vigilance & Safety ReportingMakroCare supports with reporting incidents, complaints and safety in the US, Europe and other markets
LabelingAs every label needs to change, we can assist in reworking on your IFUs and corresponding artwork (labels) accordingly.
Technical AssistanceIf your internal teams need short-term support in updating BERs or Risk management documents, we can provide custom model to fit offsite or onsite resources to work on this interactively.
Let's talk about how MakroCare can help you