Surveillance and post-certification monitoring activities
Surveillance activities to assess ongoing compliance with MDR requirements.
Surveillance activities to assess ongoing compliance with MDR requirements.
After the certificate is issued, annual surveillance audits are carried out to assess that the quality management system continuously meets the MDR requirements. Such audits can also be carried out at the premises of the manufacturer’s critical subcontractors.
Technical documentation will be requested and assessed regularly according to the established technical documentation sampling plan. How many samples are taken and for which products depends on factors such as the product category, classification, and which products have not yet been assessed.
TÜV NORD Scandinavia MNB must carry out at least one unannounced audit during a certificate period, which is five years. An unannounced audit is performed on-site at the manufacturer’s premises or those of its critical contractors to ensure that both the products and quality management system comply with the applicable MDR requirements.
The manufacturer is responsible for notifying and submitting the necessary reports to TÜV NORD Scandinavia MNB on vigilance and serious incidents, as well as any field safety corrective action. TÜV NORD Scandinavia MNB then makes an assessment of whether the certification is affected.
The manufacturer is responsible for notifying TÜV NORD Scandinavia MNB of any significant changes to the organisation, quality management system, or products. TÜV NORD Scandinavia MNB then makes an assessment of whether the change will affect the manufacturer’s compliance with applicable requirements. The manufacturer must await prior approval from TÜV NORD Scandinavia MNB before implementing the planned change.
See the MDCG 2020-3 guidance on significant changes.