Why Medical Device Manufacturers Must
Act Early to Secure a Notified Body?
Legal background
Finding and applying to a Notified Body is a critical step for manufacturers whose products are required to be certified by a Notified Body. This is particularly crucial for medical device and IVD manufacturers affected by the MDR/IVDR transition timelines. Timely and accurate notified body selection is essential to avoid costly setbacks and regulatory roadblocks.
Without a valid CE certificate issued by a Notified Body:
- You cannot legally place your product on the EU market.
- You risk missing the MDR/IVDR grace period.
- Delays in locating or contracting a Notified Body can jeopardize your go-to-market timeline.
- A rejected or incomplete application may lead to costly rework or missed launch opportunities.
Our services
How Obelis Helps You Secure a Notified Body Application
We leverage our extensive regulatory network to help manufacturers find and apply to the right Notified Body for their product type and risk class. We assist by identifying Notified Bodies within your product’s designation scope, managing communications, and preparing the required technical documentation for submission. If requested, we can submit the application on your behalf, ensuring accuracy, completeness, and compliance with current EU regulations. Our support is especially valuable for manufacturers facing long wait times or urgent deadlines to comply with MDR or IVDR. With Obelis, you do not just gain access to a Notified Body, you gain a partner committed to securing your CE certificate efficiently and effectively.
Whether you are entering the EU market for the first time or re-certifying under MDR or IVDR, Obelis connects you with the most suitable EU notified body and ensures a smooth submission process.
FAQ
Frequently Asked Questions
A Notified Body is a third-party conformity assessment body designated by the European Commission. Their scope is to evaluate whether certain products comply with the applicable European safety and regulatory requirements. They are essential for higher-risk products, such as most medical devices, in vitro diagnostics (IVDs), and other safety equipment, ensuring products meet the requirements before being placed on the EU market.
Selecting a Notified Body is necessary for most medical devices under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Without a valid CE certificate issued by a Notified Body, you cannot legally market your device in the EU. Early selection and application help avoid delays, missed deadlines, and costly compliance issues.
Choosing the right Notified Body depends on your product’s classification, intended use, and risk level. It is crucial to identify a Notified Body designated for your specific product scope, with the capacity to handle your application within your timeline. Consider factors like their expertise, workload, and communication responsiveness to ensure a smooth conformity assessment process.
Obelis leverages an extensive regulatory network to identify suitable Notified Bodies matching your product classification and regulatory needs. We assist in preparing your application, managing communications and providing assistance in the application phase. Our support reduces wait times and mitigates risks, helping you secure your CE certificate smoothly.
