MDR (Medical Device Regulation) Consulting
EU MDR Consulting Services for Medical Device Manufacturers
Independent EU MDR Consultants
MDRcert is an independent regulatory consultancy for manufacturers placing medical devices on the European market under Regulation (EU) 2017/745. We are not a Notified Body and we do not issue certificates. We prepare your device, your documentation and your team for the body that does.
Every engagement opens with a gap analysis against the requirements that actually apply to your device: the classification rules in Annex VIII, the General Safety and Performance Requirements in Annex I, and the conformity assessment route that follows from both. You receive a written gap report with findings ranked by submission impact, not a generic checklist.
If you are still mapping the regulation itself, our EU MDR 2017/745 overview covers the structure before any project starts.
End-to-End MDR Certification & Surveillance
MDR compliance does not end at CE marking. Article 83 requires a post-market surveillance system proportionate to the risk class of the device, Annex XIV Part B governs post-market clinical follow-up, and Article 86 sets the PSUR cycle for Class IIa and above.
We build the technical documentation to Annex II and III, align the clinical evaluation to Article 61 and Annex XIV Part A, and stand up the post-market workflows that keep the file current after certification.
Where your portfolio still carries MDD certificates, the transition deadlines in Article 120, as amended by Regulation (EU) 2023/607, determine the sequence of work. Our MDR transition timeline sets out what expires when.
Assess
Assessment and Gap Analysis
Plan
Regulatory Strategy and Scope
Build
Technical and Clinical Documentation
Submit
Submission and Notified Body Review
Maintain
Post-Market Compliance and Updates
What manufacturers expect from MDR consulting
Most manufacturers arrive with the same three problems: a technical file written for the MDD, a clinical evaluation that will not survive review, and no clear view of which deadline applies to which device.
MDR consulting should answer those in order. We confirm classification and conformity assessment route first, because a wrong class decision invalidates everything built on top of it. We then restructure the technical documentation to the Annex II layout a reviewer expects, and align the clinical evaluation, the ISO 14971 risk management file and the post-market surveillance plan so that all three tell one consistent story.
If your devices are still certified under the MDD, start with what actually changed: our MDD to MDR comparison sets out the structural differences that drive most remediation work.
Need clarity before your next MDR submission?
Core MDR Consulting Coverage
Testimonials
Working with MDRCert for our MDR compliance audit was a game-changer. Their thorough risk management assessment helped us achieve Notified Body approval on the ...
Dr. James Rodriguez
MDRCert guided us through our complete IVDR transition with exceptional expertise. Their team identified critical gaps in our technical documentation and provid...
Sarah David
As a first-time manufacturer, the EU MDR felt overwhelming. MDRCert became our trusted partner, guiding us from initial strategy and risk management to final su...
Ben Smith
The gap analysis conducted by MDRCert was a game-changer. They identified critical vulnerabilities in our technical file before our notified body audit. Their a...
Thomas Wright
Implementing a compliant ISO 13485:2016 QMS seemed daunting. MDRCert provided clear, pragmatic guidance tailored to our small company’s needs. They didn&#...
Maria Rodriguez
MDRCert authored a comprehensive Clinical Evaluation Report for our Class IIb device. Their report was exceptionally thorough and meticulously structured, which...
David Chen
We engaged MDRCert for our full MDR transition strategy. Their team’s deep expertise, particularly their former notified body background, was invaluable. ...
Sarah Jenkins
Frequently Asked Questions About MDR Consulting
The questions below reflect what manufacturers most often ask before starting an MDR compliance project. For the regulation itself rather than the service, see our EU MDR compliance guide.
Need a clear path to compliance? Talk to MDRCert
Tell us about your device, target market, and current stage. We will guide you on the most practical next steps.
MDRCert Regulatory Support Team
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