EU MDR and IVDR regulatory support
The EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) demand precise technical documentation, risk assessment and conformity evaluation. RIAR Consulting helps manufacturers achieve CE marking and maintain market access.
Market access under the EU device regulations
Medical devices are regulated in the EU under Regulation (EU) 2017/745 (MDR) and in-vitro diagnostic medical devices under Regulation (EU) 2017/746 (IVDR). The European Commission, national competent authorities and notified bodies each play a distinct role in the system.
RIAR Consulting assists in preparing EU-compliant technical files, coordinating with notified bodies and maintaining post-market surveillance systems, helping clients achieve timely CE marking and market access.
For medicinal products, EMA and national procedures apply; see our pharmaceutical services for Centralised, Decentralised, Mutual Recognition and National routes.
Our EU MDR and IVDR regulatory services
Support from classification and technical documentation through conformity assessment and post-market obligations.
- 01
Regulatory strategy and classification
- Device and IVD classification under the applicable rules
- Identification of the conformity assessment route
- Regulatory gap assessment against MDR or IVDR requirements
- Market-entry planning
- 02
Technical documentation
- Preparation and review of EU-compliant technical files
- General safety and performance requirements documentation
- Risk management documentation
- Labelling and instructions for use review
- 03
Clinical and performance evaluation
- Clinical evaluation documentation for medical devices
- Performance evaluation documentation for IVDs
- Coordination of supporting evidence
- 04
Notified body coordination
- Coordination with notified bodies
- Preparation for conformity assessment review
- Responses to notified body questions and findings
- 05
Post-market surveillance and vigilance
- Establishing and maintaining post-market surveillance systems
- Vigilance support
- Renewals, changes and ongoing compliance
- 06
Medicinal products in the EU
- EMA and national authorisation procedures are covered under our pharmaceutical services
- CTD/eCTD dossiers, variations and lifecycle management
A structured approach to CE marking
Each engagement follows the same structured sequence, adapted to the device, its classification and the conformity assessment route:
- Understanding the device or IVD, its intended purpose and your market objectives
- Confirming classification and the applicable conformity assessment route
- Identifying gaps in technical documentation, risk management and clinical or performance evidence
- Preparing and organising technical documentation to MDR or IVDR requirements
- Coordinating with the notified body through review and certification
- Supporting post-market surveillance, vigilance and ongoing compliance
Our objective is to help manufacturers approach EU MDR and IVDR requirements with complete documentation and a clear route to CE marking.
How VERA 2.0 supports this sector
Device and IVD conformity depends on controlled, consistent manufacturing. VERA 2.0 is being developed for regulated manufacturing environments and can extend that visibility to device and IVD production sites.
- VERA 2.0
Controlled-environment monitoring
Visibility into cleanroom and HVAC conditions such as airflow, differential pressure, temperature, humidity and particulates, where supported by connected systems.
- VERA 2.0
Equipment and process visibility
Monitoring of selected equipment and process conditions to help identify unusual behaviour that could affect product consistency.
- VERA 2.0
Investigation support
Event records and contextual advisories help authorised personnel investigate production issues that may feed post-market surveillance.
- VERA 2.0
Audit-ready context
A structured record of observations and advisories supports internal reviews ahead of notified body audits.
VERA 2.0 is being developed with pharmaceutical manufacturing in mind; its applicability to a device or IVD site is assessed against that site’s systems. VERA is advisory only: it does not write to or control plant systems, and it does not replace the quality management system or conformity assessment.
Preparing for EU MDR or IVDR?
Whether you are classifying a new device, preparing technical documentation or responding to notified body findings, RIAR Consulting can support your regulatory objectives.