Your Partners for MDR Compliance
Navigate the complex details of MDR with our experts
The Medical Device Regulation (MDR) changes the legal framework for medical devices in Europe.
The MDR became fully applicable beginning in May 2021. The transition period from the former regulation framework Medical Devices Directive (MDD), during which manufacturers must recertify medical devices in accordance with the new regulation, was originally scheduled to last until May 2024.
We already support manufacturers asking questions like:
- Do these new requirements impact my device?
- Will I be able to benefit from what is outlined in the proposal?
- What should I do next?
Our MDR solutions are backed by expertise
- Product Classification, Strategy, Target Product Profile and Roadmap Development
- Regulatory Framework establishment (Scientific Advice, Pre-Sub meetings, and more)
- Gap Analysis
- Technical Documentation compilation
- Global Regulatory Intelligence and Due Diligences
- Notified Bodies selection, interactions management, and liaison during revision
- Lifecycle Maintenance (incl. establishment of PMS requirements)
Medical Device Regulation:
Why partner with Alira Health on MDR?
- +100 EMA/FDA/EU MS Agencies direct interaction submission experience
- Internal team of 30+ Regulatory Experts
- We Advise 75% of the Top 50 Pharma Companies
- Local insights, Global Reach: Offices in 11 countries across North America, Europe, and Asia Pacific; 20+ languages spoken, enabling great proximity with our clients
Regardless of where you stand today,
Alira Health is here to help you manage the transition to the MDR
As regulatory consultants, we can prepare you to take advantage of the benefits offered in the extended transition.