Medical Device Regulation Certification (MDR)
Technical guidance and regulatory support for medical device manufacturers preparing for compliance with the EU Medical Device Regulation (MDR)
Our services focus on regulatory readiness for EU market access through structured evaluation of technical documentation, regulatory classification, and conformity assessment preparation activities.
MDR compliance requires a structured approach covering technical documentation, clinical evidence, risk management, quality management systems, and post-market surveillance requirements.
our approach to Medical Device Regulation (EU) 2017/745 certification
The applicable conformity route depends on device classification, intended purpose, and regulatory requirements, including involvement of a Notified Body where applicable.Typical device categories include:
Diagnostic devices
Therapeutic devices
Medical software
Implantable devices
Non-implantable devices
Medical accessories
The Medical Device Regulation (EU) 2017/745 establishes the regulatory framework for medical devices placed on the European market. MDR introduces enhanced requirements related to:
- Clinical evaluation and clinical evidence
- Risk management
- Technical documentation structure and completeness
- Post-market surveillance (PMS)
- Traceability and device identification
Medical Device Regulation (EU) 2017/745 CERTIFICATION PROCESS
Classification and Regulatory Review
Assessment of intended purpose and device classification to determine applicable MDR requirements and conformity route.
Documentation Gap Assessment
Evaluation of technical documentation completeness, including identification of gaps in MDR-required deliverables.
Evidence and Documentation Planning
Support in structuring clinical, technical, and risk management evidence required for MDR compliance.
Conformity Assessment Preparation
Preparation of documentation packages for interaction with Notified Bodies and conformity assessment procedures.
WHY DANEM TEST & CERTIFICATE
- Global Expertise
International team supporting certification and compliance projects worldwide - Independent Assessment
Transparent and impartial certification, testing, and audit processes - Prompt communication and fast response times. Faster certification and testing processes through responsive communication, streamlined workflows, and continuous project oversight
- Structured Certification Pathways
Clear project planning from assessment through approval - Technical & Regulatory Knowledge
Support across certification, testing, regulatory requirements, and market access.
FAQ
ask us
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Does MDR apply to my product, and how is device classification determined?
MDR applies to medical devices and certain accessories and software placed on the EU market. Classification depends on intended purpose, risk profile, and applicable MDR rules, which we confirm during the initial review.
Is a Notified Body always required under MDR?
Not always. Notified Body involvement depends on device class and applicable route. We help confirm whether Notified Body assessment is required for your device.
What are the most common gaps found during MDR readiness reviews?
Frequent gaps include incomplete clinical evidence planning, weak traceability between claims and evidence, missing post-market surveillance planning, and outdated risk management documentation. Early gap assessment reduces rework.
Can existing MDD documentation be reused for MDR?
Often yes, but it typically requires updates and restructuring to match MDR expectations. We help map existing documentation to MDR requirements and identify what needs to be added or improved.
How long does MDR preparation typically take?
Timelines depend on device class, documentation maturity, clinical evidence needs, and organizational readiness. A structured plan and early gap assessment help make timelines predictable.