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
- 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.
Read the latest updates on Notified Bodies in our news section.
Click here and connect with Med-Di-Dia for a free consultation.
Call Now: +353 (0)91-704804
Send An Email: firstname.lastname@example.orgBack...