The EU In-Vitro Diagnostic Regulation (IVDR) has applied since May 26, 2022, significantly changing regulatory requirements for IVDs. Under IVDR, devices are classified into four risk-based categories, and all classes except Class A require involvement of a Notified Body (NB) for conformity assessment.
As a result:
- Approximately 85% of IVDs now require a CE Certificate issued by a Notified Body to enter the EU market.
- Under the previous IVDD framework, only 8% of IVDs required NB involvement.
- Currently, only 10 Notified Bodies have been designated under IVDR, creating limited capacity.
Here’s how to approach IVDR certification efficiently:
1. Plan and Allow Sufficient Time
According to a survey conducted by the European Commission, 60% of manufacturers take between 13 and 18 months to reach IVDR certification for their quality management systems (QMS) and products. 30% need between 19 and 24 months. The main reason is that submissions are largely incomplete.
With over 35 years of experience, Obelis can help you streamline the IVDR compliance process:
- Review your documentation
- Identify and close gaps
- Provide supporting tools and guidance
2. Compile Technical Documentation and Regulatory Strategy
Understanding your conformity assessment procedure and transitioning from IVDD to IVDR compliance is crucial.
Obelis can support you with:
- Templates and checklists for essential documentation
- Regulatory strategy tailored to your devices
- Continuous guidance from expert consultants
3. Engage a Notified Body Early
Notified Bodies have limited capacity due to high demand. Securing your NB early is critical to avoid delays.
Obelis offers a dedicated service to help you:
- Contact Notified Bodies on your behalf
- Negotiate and present offers
- Manage administrative procedures, so you can focus on your business
Make IVDR Compliance Easier with the Right Partner
Meeting IVDR requirements can be challenging, but the right regulatory partner makes the process smoother. Obelis offers a full range of services for IVD regulatory compliance, guiding manufacturers to place their devices on the EU market efficiently.
With experience helping over 3,000 manufacturers from 60+ countries, Obelis can help ensure your IVDR certification process is faster and more reliable.
FAQ
1. What is IVDR?
The In-Vitro Diagnostic Regulation (IVDR) is EU Regulation 2017/746 that sets updated rules for in-vitro diagnostic (IVD) devices, replacing the previous IVDD framework. It classifies IVDs into four risk categories and requires most devices to involve a Notified Body for CE certification.
2. Which IVDs require a Notified Body under IVDR?
All IVDs except Class A devices require involvement of a Notified Body for conformity assessment. This means approximately 85% of IVDs now require CE certification from a Notified Body to enter the EU market.
3. How long does the IVDR certification process take?
Certification timelines vary:
- 60% of manufacturers take 13–18 months
- 30% take 19–24 months
Delays are often due to incomplete submissions or missing documentation.
4. What documents are needed for IVDR certification?
Key requirements include:
- Technical documentation for each device
- Quality Management System (QMS) records
- Conformity assessment strategy and evidence of compliance
5. How can I prepare for IVDR compliance?
- Plan ahead and allocate sufficient time for certification
- Compile and review technical documentation
- Identify the correct conformity assessment procedure for your devices
6. When should I approach a Notified Body?
Engage a Notified Body as early as possible due to limited capacity. Only 10 Notified Bodies are currently designated under IVDR, so early engagement helps avoid delays.