MDR
Compliant with the MDR
The MDR sets requirements for the safety, performance and documentation of medical devices throughout their lifecycle.
Book an introductory call- Governance, risk & compliance
- Audit & compliance
When the MDR applies
The MDR has fully applied since May 2021, with transition periods for existing devices running out.
Manufacturers and distributors of medical devices must show devices are, and remain, safe, even after being placed on the market.
Your organisation develops, manufactures or distributes medical devices
A certificate under the old directive is expiring
There is no structured process yet for post-market surveillance
What incidents noticed too late cost
Without a valid conformity assessment, a device may not be placed or remain on the European market.
Insufficient post-market surveillance increases the risk of incidents being noticed late, with consequences for patient safety and liability.
What the law asks of your device
The MDR requires a conformity assessment matched to the risk class, clinical evaluation, and ongoing monitoring after the device is placed on the market.
A conformity assessment, often through a notified body
Clinical evaluation and technical documentation
Registration in EUDAMED and Unique Device Identification (UDI)
A person responsible for regulatory compliance (PRRC) within the organisation
Post-market surveillance and vigilance
From classification to post-market surveillance
Vedeum helps structurally embed MDR obligations, from conformity assessment to post-market surveillance.
Baseline assessment
We map the current situation against the MDR.
Classification
We determine the risk class and the corresponding conformity route.
Implementation
We help set up documentation, the PRRC role and processes.
Embedding
We support post-market surveillance and periodic review.
Book a no-obligation introductory call
Tell us where your organisation stands. We will think through the first steps with you.
Book an introductory call