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?

Medical Device Regulation in 2023: A Window of Opportunity

Start Reading

Our MDR solutions are backed by expertise

As regulatory consultants, we help our clients in the management of the transition to both the MDR and IVDR as we identify and prioritize requirements, build a strategy to implement the scientific requirements, and understand the impact of the proposed extension.

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:
A Checklist for Preparation

This checklist can provide you with insight into where you stand in regards to MDR preparation and what you still need to address.

Download Checklist

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

Ainoa Forteza presenting

Thanks to our cross-functional team spread between the US and EU, and an extensive network of consultants and KOLs, we ensure tailored strategies, efficient interactions, and successful submissions.

Ainoa Forteza

Vice President, Regulatory Affairs

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.

Our Services