Regulatory Affairs
EU MDR and IVDR Compliance
CE marking, technical documentation, and Notified Body strategy for Europe.
What It Is
The EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) govern access to the European market. Compliance means building technical documentation that meets the General Safety and Performance Requirements, a clinical evaluation (CER) or performance evaluation (PER), a compliant ISO 13485 quality system, post-market surveillance and vigilance systems, and — for most devices — conformity assessment by a Notified Body to earn the CE mark.
When You Need It
You need MDR/IVDR support when entering or maintaining the EU market, when transitioning legacy CE certificates under the regulation’s timelines, when your IVD has been up-classified under IVDR, or when you need a compliant technical file and CER/PER for Notified Body review.
What We Do
We perform a gap assessment against MDR/IVDR, build or remediate the technical documentation, author or update the Clinical Evaluation Report or Performance Evaluation Report, align your ISO 13485 system to the regulation’s requirements, stand up post-market surveillance and PMCF/PMPF plans, and support Notified Body selection and submission. We also act as the bridge between your U.S. and EU regulatory strategies so they reinforce rather than duplicate each other.
We Live It, Not Just Advise It
A Notified Body audit of your quality system is a core part of MDR/IVDR conformity. We are audited routinely against ISO 13485 in our own operation — we prepare your technical file and QMS knowing precisely what an auditor will open first, because the same documents get opened in ours.
How AuditIQ Helps
AuditIQ helps assess your technical documentation and QMS against MDR/IVDR requirements, prioritizing the gaps most likely to draw a Notified Body nonconformity.
Learn more about AuditIQ →Frequently Asked Questions
What is the difference between MDR and IVDR?
MDR (2017/745) governs medical devices; IVDR (2017/746) governs in vitro diagnostic devices. IVDR substantially raised the bar for IVDs, up-classifying many products and requiring Notified Body involvement for the majority, where most previously self-certified.
Do I need a Notified Body?
Most devices above the lowest risk class require conformity assessment by a Notified Body to CE mark under MDR/IVDR. Only the lowest-risk, self-certified classes avoid it. We help you determine your route and select an appropriate Notified Body.
Can my U.S. testing be reused for Europe?
Often substantially, yes. Biocompatibility, sterilization, electrical safety, and much performance testing follow harmonized international standards usable on both sides of the Atlantic. We plan testing once, to serve both markets where possible, to avoid paying twice.
Ready to Talk Through Your EU MDR / IVDR Project?
Tell us where you are in the process. We respond within one business day.
Request a ConsultThe Boulder BioMed Family
One campus, one quality system. We manufacture, sterilize, and test medical devices in-house — so our regulatory and quality work is grounded in operations, not theory.