IVDR (In Vitro Diagnostic Regulation) Consulting
IVDR Consulting Services for In Vitro Diagnostic Manufacturers
Independent EU IVDR Consultants
MDRcert is an independent regulatory consultancy for manufacturers placing in vitro diagnostic medical devices on the European market under Regulation (EU) 2017/746. We are not a Notified Body and we do not issue certificates. We prepare your device, your evidence and your team for the body that does.
Every engagement opens with the two decisions that shape everything after them: the intended purpose you claim, and the class that follows from it. The seven classification rules in Annex VIII place most IVDs in Class B or above, which means a Notified Body where the IVDD required none. You receive a written gap report with findings ranked by submission impact, not a generic checklist.
If your portfolio also contains non-diagnostic devices, MDR applies to those instead. Our MDR consulting service covers that side.
Performance Evidence That Survives Review
IVDR replaces the IVDD technical file with a performance evaluation built on three pillars: scientific validity, analytical performance and clinical performance. Article 56 and Annex XIII set what each pillar must demonstrate, and a weakness in any one of them stalls the whole submission.
We build the technical documentation to Annex II and Annex III, assemble the performance evaluation plan and report to Annex XIII Part A, and stand up the post-market performance follow-up that Annex XIII Part B requires after certification.
Where your portfolio still carries IVDD certificates, the transitional deadlines in Article 110, as amended by Regulation (EU) 2024/1860, decide the order of work: 31 December 2027 for Class D, 31 December 2028 for Class C, and 31 December 2029 for Class B and sterile Class A.
Assess
Classification, Intended Purpose and Gap Assessment
Plan
Regulatory Strategy and Conformity Route
Build
Performance Evaluation and Technical Documentation
Submit
Notified Body Submission and Deficiency Response
Maintain
PMS, PMPF, SSP and Ongoing IVDR Governance
What IVD manufacturers need before IVDR submission
Most IVD manufacturers arrive with the same problem: a file written for the IVDD, where self-certification covered the large majority of the portfolio, and no performance evaluation that would satisfy a Notified Body.
IVDR consulting should fix that in order. We confirm intended purpose and class first, because Annex VIII decides whether you need a Notified Body at all and a wrong call invalidates everything built on top of it. We then restructure the technical documentation to Annex II, assemble the performance evaluation across all three pillars, and align the ISO 14971 risk management file and the post-market surveillance plan so that all three tell one consistent story.
If you are still deciding which markets to enter and in what order, our registration strategy service sequences the submissions before the documentation work begins.
Planning an IVDR submission in the next 3 to 12 months?
Core IVDR 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 IVDR Consulting
These are the questions IVD manufacturers most often ask before starting an IVDR submission or transition programme. For the full range of regulatory support we offer, see our consulting services.
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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