Expert IVDR compliance and CE marking support
OPERON-RA grants you expert knowledge and hands-on support in preparing to fulfill IVDR regulatory requirements, to achieve market authorization as early as possible.
ABOUT
OPERON Regulatory Affairs specializes in market access strategies for In-Vitro Diagnostic devices under the European IVDR.
As a small consultancy located at the heart of Europe (Maastricht, Netherlands), you can count on industry expertise and services which are tailored to meet your CE Marking objectives and timelines.
Founder / Initiator
Pieter Caesens
As a marketer of RUO lab technologies, Pieter understands what it takes to commercialize complex products. At OPERON RA, he pairs this with regulatory insight into IVD and medical device labeling, turning compliance into competitive advantage.
To help IVD manufacturers meet EU regulatory requirements, obtain CE marking, and achieve market access efficiently and effectively, OPERON Regulatory Affairs provides the following services:
IVDR Regulatory Strategy and Market Access Consulting
- Strategic advice to determine the most efficient pathway to market entry based on the specific nature of your IVD product.
- In-depth analysis of product classifications under the IVDR and guidance on transitioning from the IVDD.
- Development of customized market access plans, taking into account regulatory, commercial, and operational factors.
Technical Documentation and CE Marking Support
- Comprehensive review and preparation of technical documentation in line with Annex III of the IVDD or Annex II of the IVDR.
- Assistance with performance evaluation reports, risk management files, and clinical evidence requirements.
- Support for achieving and maintaining CE marking for your IVD products.
EU Regulatory Compliance Guidance
- Expertise in navigating the IVDR’s classification rules and Notified Body conformity assessment procedures.
- Guidance on transitioning from IVDD to IVDR, including timeline planning and compliance gap assessments.
- Advice on compliance with post-market surveillance and vigilance obligations under EU law.
To ensure expert advice and guidance in all relevant fields, OPERON Regulatory Affairs works together in partnership with medical writers, notified bodies, laboratories and quality control consultants.
Regulatory services cover all European Union countries for IVDR 2017/746 and for adjacent regulations such as MDR 2017/745.
Are you facing a challenge or do you have a question? We are happy to help you.