Who this is for
Medical-device manufacturers preparing or remediating an EU MDR technical and conformity-assessment pathway.
Medical Devices
EU MDR Market-Access Support for Medical Devices
Prepare a device-specific route to EU market access under the MDR. ConformArc coordinates classification, technical-documentation gaps, evidence planning and assessment readiness. The manufacturer retains its regulatory responsibilities, and any required notified-body assessment is performed by an appropriately designated body.
Typical scope
- Intended-purpose and classification review
- Technical-documentation gap map
- Risk-management and evidence workstream coordination
- Clinical-evaluation and PMS/PMCF input planning where applicable
- Labelling/UDI readiness review
- Notified-body readiness coordination where required
Useful inputs for an initial review
- Intended purpose and device variants
- Existing classification rationale
- QMS and technical documentation
- Risk-management and clinical/performance evidence
- Testing reports
- Labelling and post-market information
Accuracy note. IVDs are outside this MDR page scope; IVDR is a separate framework. Not every device requires the same third-party assessment route.
Role clarity. ConformArc provides project scoping, readiness support and coordination within an agreed service scope. Where independent testing, certification, verification or regulatory review is required, the relevant work and decisions remain with the appointed laboratory, assessment body, verifier or authority. Outcomes and timelines depend on the product, evidence and applicable requirements.
Frequently asked questions
Does every medical device need notified-body involvement?
No. The conformity route depends on classification and applicable requirements.
Is CE marking just a certificate purchase?
No. The manufacturer must meet the applicable regulatory obligations and maintain the required evidence and responsibilities.
Can one evidence package cover every market?
Not automatically. Evidence can overlap, but market-specific requirements and accepted routes still need review.
Need a clearer route before you commit to testing or certification?
Share the product, target market and current project stage. ConformArc will review the enquiry, identify the likely workstreams and confirm what information is needed next. Any specialist work, laboratory activity, certification assessment, regulatory submission or verification scope is agreed separately.