EU MDR, navigated properly.
EU MDR consulting for medical device software — classification, CE marking strategy and conformity assessment planning, with the technical documentation and Notified Body engagement to see it through.
What we do for EU-bound programmes.
Classification drives everything that follows. We settle it early, then build the evidence and the conformity assessment plan around it.
EU MDR strategy
Defining the route to CE marking, target timelines and the evidence required to support them.
SaMD / software classification
Applying Rule 11 and the wider classification rules to medical device software, with a defensible rationale.
CE marking strategy
Establishing the applicable general safety and performance requirements and how each will be demonstrated.
Conformity assessment planning
Selecting and planning the appropriate conformity assessment route, including Notified Body involvement for higher-risk classes.
Technical documentation
Compiling Annex II and III documentation, with traceability from requirements to verification evidence.
Notified Body preparation and support
Readiness ahead of assessment, plus support through questions, non-conformities and responses.
Post-market regulatory requirements
PMS plans, PMCF, periodic reporting and vigilance obligations that keep the CE marking valid.
There is no EU 'registration' that grants market access for a medical device. Compliance with the EU MDR is demonstrated through conformity assessment — involving a Notified Body for higher-risk classifications — and evidenced by the Declaration of Conformity and CE marking. Planning around the correct mechanism from the outset avoids the most expensive kind of late surprise.
Heading for CE marking?
We'll confirm your classification, the conformity assessment route and what your technical documentation still needs.