The EU IVDR (Regulation on in-vitro diagnostic devices) applies as of May 26, 2022, profoundly changing the regulatory requirements for IVDs. The IVDR establishes rules to classify IVDs into four categories based on risk, and all classes except for Class A IVDs need to involve a Notified Body (NB) in the conformity assessment. As a result, around 85% of IVDs need a CE Certificate issued by a NB to enter the EU market. Conversely, under the previous list-based approach (IVDD), only 8% of IVDs needed a Notified Body. To make it even more challenging, at the moment, only 10 Notified Bodies have been designated under IVDR.
Here are our solutions to effectively approach this change and place your IVDs on the EU market.
1. Plan and consider the time needed.
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 35 years of experience in regulatory compliance, we can guide you in the IVDR compliance process and shorten the certification process. We review your documentation, identify the gaps to cover, and provide you with supporting tools.
2. Compile the technical documentation and regulatory strategy
Identify the conformity assessment procedure for your devices, how to move from IVDD to IVDR compliance and communicate with the Notified Body.
Do you need guidance in establishing these essential documents? We can help you with templates, checklists, and the constant support of our expert consultants.
3. Approach a Notified Body as soon as possible.
Notified Bodies’ capacity is limited due to the high number of requests and the fact that only 10 NB have been designated to issue IVDR CE Certificates. Thus, you should secure your place at the soonest! At Obelis, we have a dedicated service to help you with this — We contact Notified Bodies on your behalf, negotiate with them, and present you, their offers. This way, you can focus on your business without worrying about administrative procedures.
Meeting the new IVDR requirements can be challenging, but the process will become easier with the right regulatory partner by your side. Obelis offers a wide range of services for regulatory compliance of IVDs — Our consultants will guide you and ensure you can place your devices on the EU market as smoothly as possible. We have helped over 3,000 manufacturers from over 60 countries; the next can be you!