EU MDR Consulting and CE Marking Support
BioVision's consultants provide full support for CE marking under the EU Medical Device Regulation (MDR 2017/745), including the transition from
the older Medical Devices Directive (MDD). We prepare your technical documentation, manage the Notified Body relationship, and build the
post-market system the MDR requires.
What the EU MDR requires
MDR 2017/745 raised the bar for clinical evidence, technical documentation, post-market surveillance, and traceability compared to the previous MDD. Key obligations include:
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Technical documentation demonstrating conformity with the General Safety and Performance Requirements (GSPRs).
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Clinical evaluation and ongoing Post-Market Clinical Follow-up (PMCF).
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Unique Device Identification (UDI) and registration in EUDAMED.
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A Person Responsible for Regulatory Compliance (PRRC).
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A robust post-market surveillance (PMS) system.
Transitioning from MDD to MDR
Devices previously CE-marked under the MDD must be brought into compliance with the MDR. BioVision conducts a gap assessment, builds a remediation plan, and prepares the updated documentation your Notified Body will require — minimizing the risk of losing market access.
How BioVision supports your CE marking:
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Device classification under MDR rules.
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GSPR checklist and gap analysis.
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Technical documentation preparation.
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Clinical Evaluation Report (CER) support.
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Notified Body selection and liaison.
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PMS and PMCF system setup.
Frequently Asked Questions
What is the difference between the MDD and the MDR?
The MDR (2017/745) replaced the MDD with significantly stricter requirements for clinical evidence, documentation, traceability, and post-market monitoring. Most manufacturers found re-certification under MDR substantially more demanding.
Do I need a Notified Body for CE marking?
Most devices above Class I require assessment by a Notified Body. Only certain low-risk Class I devices can self-declare conformity. BioVision helps you determine your route and engage the right Notified Body.
What is a PRRC?
The Person Responsible for Regulatory Compliance is a mandatory role under MDR. The individual must have defined qualifications and oversees regulatory compliance and post-market obligations.