Notified Bodies in EU MDR 

 

What are Notified Bodies – EU MDR?

As an indispensable part of the regulatory system, Notified Bodies are responsible for assessing medical devices (MDs) and diagnostics (IVDs). These bodies grant a CE mark to each device before it can be placed in the EU market by the manufacturer.

 

Critical Facts about EU MDR Notified Bodies

• Impartial
• Independent
• Grant EU wide approvals
• Identified with a 4 digit number placed with the CE Mark
• Private or Public registration

All existing and new notified bodies need to be designated to prove their competence in assessing products and quality systems under the increased requirement of the new regulations. This designation process includes four steps and is expected to take an average of 18 months per Notified Body.

 

Step 1 – Pre-Assessment and Off-site Activities

Step 2 – On-Site Assessment activities and CAPA (plan for corrective and preventive actions)

Step 3 – Post Assessment Activities

Step 4 – Notification in EC NANDO database.

 

How are the notified bodies controlled?

• The competence of the notified body should be subject to verification carried out at regular intervals and following the practice established by the accreditation organisations.
• The EN ISO/IEC 17000 series of standards and accreditation are important instruments to help establish conformity with the requirements of applicable legislation.

Over the years, the involvement of Notified Bodies in certifying medical technologies has evolved, and it is currently experiencing another significant revamp with the new CE Marking Regulations adopted in 2017.

This leads to a situation where fewer and fewer Notified Bodies must now deal with more extensive work. The gap between Notified Bodies’ capacity and the existing workload increases significantly. According to the new Medical Device and In Vitro Diagnostic Regulations, Notified Bodies are undergoing a significant revamp to comply with their greater obligations.

 

Role of Notified Bodies 

Notified Bodies play a crucial role in the regulatory process for medical devices in the EU. They are responsible for 

 

1. Conformity Assessment: Manufacturers of medical devices must demonstrate that their products meet the essential requirements for safety and performance outlined in the MDR or IVDR. They do this through a conformity assessment process. Notified Bodies assess the technical documentation and design of the devices to determine if they comply with these requirements.

2. Certification: If a Notified Body determines that a medical device conforms to the regulatory standards, it issues a CE (Conformité Européenne) certificate to the manufacturer. The CE mark allows the device to be marketed and sold within the European Economic Area (EEA).

3. Ongoing Surveillance: Notified Bodies also play a role in post-market surveillance. They monitor the performance and safety of medical devices on the market, especially for higher-risk devices. This includes conducting periodic audits and inspections of manufacturers and reviewing any adverse event reports.

4. Advisory Role: Notified Bodies may provide expertise and guidance to manufacturers throughout the product development and regulatory compliance process.

5. Changes and Renewals: Manufacturers must notify Notified Bodies of any significant changes to their devices or manufacturing processes. Notified Bodies evaluate these changes to ensure continued compliance with regulations. They also participate in the renewal of certificates to ensure ongoing compliance.

 

Read the latest updates on Notified Bodies in our news section.

 

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