The Medical Device Coordination Group (MDCG) has released its updated guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams. The purpose of this guidance is to guide conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) in compliance with Regulation (EU) 2017/745 on medical devices (hereafter MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
This guidance outlines the requirements for CABs, NBs, DAs and JATs on using the templates in Annex I and Annex II during assessments of NBs and CABs under the MDR and the IVDR.
The guidance provides standardized templates to be used by notified bodies and joint assessment teams to document conformity assessments, audit findings, and other key regulatory activities. These templates promote consistency in documentation and ensure clear communication between regulatory bodies, notified bodies, and manufacturers.
Conformity assessment is a procedure conducted by manufacturers or third-party organizations (such as notified bodies) to verify that a medical device meets the regulatory standards required for market approval. It often involves reviewing technical documentation, conducting audits, and, in some cases, performing product testing.
Notified bodies are independent organizations designated by regulatory authorities to carry out conformity assessments for certain types of medical devices, typically those that present a higher risk. They review the technical documentation, conduct quality system audits, and, if necessary, perform product testing to certify that a device meets the applicable regulatory requirements.
Designating Authorities are national regulatory bodies responsible for designating and monitoring the performance of Notified Bodies.
Joint Assessment Teams (JATs) are specialized teams formed to conduct the joint assessment of Notified Bodies during their designation process under regulations like the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). JATs play a critical role in ensuring that Notified Bodies meet the required standards to assess medical devices or in vitro diagnostic devices for safety and performance.
The guidance sets out the reporting obligations for notified bodies and the designating authorities, along with mechanisms for continuous monitoring to ensure ongoing compliance with regulatory standards. Also the guidance details the Timelines, Correction, Root cause(s) and the cooperation between notified bodies, designating authorities, and the European Commission to enhance the effectiveness of regulatory oversight and ensure consistent application of the MDR and IVDR regulations across member states.
For more detailed information, you can refer to the full document here.
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