Where do Notified Bodies come from?
The designation of Notified Bodies in the European Union is a complex and regulated process.
The process begins with a Notified Body applying to the National Competent Authority (NCA) of an EU member state for designation. The NCA is the regulatory body responsible for medical devices in each member state.
The NCA thoroughly evaluates the application submitted by the Notified Body. This evaluation includes an assessment of the Notified Body's expertise, competence, available resources, and its ability to carry out conformity assessments for specific types of medical devices.
Based on the evaluation, the NCA decides whether to designate the Notified Body. If the NCA is satisfied that the Notified Body meets the required standards, it issues a designation certificate. The NCA notifies the European Commission about the designation of the Notified Body. The European Commission maintains a publicly accessible database of Notified Bodies.
Once designated, the Notified Body is subject to ongoing monitoring and oversight by both the NCA and the European Commission. This includes regular audits and assessments to ensure continued compliance with regulatory requirements.
The designation of Notified Bodies is a national responsibility, and each EU member state designates its own Notified Bodies. However, the designations are subject to approval by the European Commission.
What do Notified Bodies do?
Notified Bodies play a pivotal role in the certification process for medical devices in the European Union. Their responsibilities extend across various stages of the device lifecycle, and their assessments are integral to obtaining and maintaining the CE marking.
Notified Bodies are responsible for conducting the conformity assessment of medical devices, including technical documentation, quality management system and manufacturer's R&D and production sites. This assessment ensures that a device meets the general safety and performance requirements and applicable standards outlined in the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).
If the Notified Body is convinced that the device meets all relevant requirements, it issues a Certificate of Conformity. This certificate allows the manufacturer to affix the CE marking to their device, indicating compliance with EU regulations.
The role of Notified Bodies doesn't end with the issuance of the certificate. They continue to monitor and conduct surveillance activities to ensure that certified devices maintain compliance throughout their lifecycle.
What countries are covered by a Notified Body?
Notified Bodies designated in one EU member state can operate across the entire EU market due to the principle of mutual recognition. The designation by one member state is generally recognized by other member states.
The principle of mutual recognition is grounded in the vision of creating a single European market for medical devices. Rather than having each member state assess and certify medical devices independently, mutual recognition facilitates the acceptance of certifications issued by Notified Bodies across all member states.
While designation is a national responsibility, the European Commission plays a crucial centralized role in overseeing the process. It ensures that the criteria for designation are consistently applied across member states and that Notified Bodies maintain the necessary competence.
How to choose the right Notified Body?
Choosing the right Notified Body is a critical decision for manufacturers of medical devices. The NB plays a central role in the conformity assessment process and certification, impacting the market access and success of the product.
First off, check what Notified Bodies are officially designated by an EU member state. You can verify this designation through the New Approach Notified and Designated Organisations (NANDO) Information System maintained by the European Commission.
Ensure that potentially suitable Notified Bodies are designated for the specific type of medical device or devices you are manufacturing. Notified Bodies often have specific expertise in certain device categories, so choose one that aligns with your product.
NBs are very busy. Consider the Notified Body's capacity to handle your project within your desired timelines. Some Notified Bodies may have a higher workload or longer lead times. It's crucial to ensure that they can meet your certification deadlines without compromising the thoroughness of the assessment.
Understand the Notified Body's approach to audits and assessments. A transparent and collaborative approach, where the Notified Body works with manufacturers to achieve compliance, is often preferred.
While cost is a factor, it should not be the sole determinant. Understand the fee structure of the Notified Body and ensure it aligns with your budget. However, prioritize competence and reliability over cost to avoid potential issues during the certification process.
Remember that the choice of Notified Body can significantly impact your device's certification process and market access. Take the time to thoroughly evaluate options, and consider seeking advice from regulatory consultants or industry peers who have experience with specific Notified Bodies.
