Measures taken against COVID-19 significantly affects the ability of notified bodies to conduct mandatory on-site inspections under the medical device’s legislation as well as annual monitoring activities of designating body, Turkish Medicines and Medical Devices Agency (“TITCK”) over notified bodies. With this respect, TITCK has recently issued a Circular regarding the activities of notified bodies operating in the field of medical devices and renewal of designation and monitoring of notified bodies during COVID-19 in accordance with the current EU Commission Implementing Regulation regarding the renewal of designation and surveillance and monitoring of notified bodies and the Medical Device Coordination Group (“MDCG”) guidance documents. TITCK monitors and evaluates whether the notified bodies comply with the relevant regulations pursuant to the Communique on Notified Bodies Operating in the Field of Medical Devices (“Communique”), which is in compliance with the EU legislation regarding medical devices. However, with current amendments due to COVID-19, TITCK’s Circular sets new rules to be followed regarding pandemic measures by notified bodies as well as TITCK.
TITCK’s Procedure and Principles Regarding its Surveillance and Monitoring Activities
Some of the principles that TITCK must comply while carrying out the mandatory surveillance and monitoring activities on notified bodies within the scope of the Communique are listed as following under the Circular. These principles are not applied to initial designation or extension of the scope of a notified body:
- In cases where on-site surveillance assessments or witness inspections are temporarily blocked due to extraordinary circumstances arising from the COVID-19 pandemic (such as travel restrictions and quarantine measures), TITCK will take all necessary measures to ensure adequate and appropriate level of surveillance activities are carried out regarding notified bodies.
- TITCK will evaluate the inspections made by notified bodies on the technical documentation of the manufacturer, including clinical evaluation, to ensure that the surveillance activities are carried out at the appropriate level by notified bodies. With this respect, TITCK will examine a sufficient and appropriate number of notified body personnel files.
- While determining the appropriate number of inspections by notified bodies on the manufacturer's technical documentation and in the selection of personnel files to be examined, in order to make an adequate assessment, TITCK will consider the volume of activities by notified bodies, the organization's designation scope and all relevant vigilance data.
- TITCK; as a part of the surveillance and monitoring activities, will examine notified bodies as from the date of the last on-site assessment, alongside with the changes regarding the organizational and general requirements in Annex II of the Communique.
- TITCK may take alternative surveillance measures which may include replacing on-site surveillance assessments with remote surveillance assessments using available advanced Information and Communication Technologies deemed appropriate in accordance with relevant legislation on information security and data protection or assessing relevant and required documents or records off-site.
Procedures and Principles Regarding the Certification Activities of Notified Bodies
Pursuant to the Circular, notified bodies may take extraordinary measures instead of on-site inspections temporarily. Such measures may include postponing on-site surveillances in line with documented procedures of the notified body regarding force majeure, replacing on-site surveillance inspections with remote surveillance inspections using available advanced Information and Communication Technologies deemed appropriate in accordance with relevant legislation on information security and data protection, assessing relevant and required documents or records off-site, considering existing recent results from Medical Device Single Audit Program (MDSAP) audits (or other appropriate audits) if available, or considering published international guidelines such as the International Accreditation Forum’s (“IAF”). The following inspections of notified bodies are under the scope of the Circular with this respect:
- Surveillance and recertification inspections within the scope of the Medical Device Regulation,
- Notifications of changes by manufacturers to a notified body which typically require on-site inspection or verification,
- In cases where a manufacturer terminates its contract voluntarily or mandatorily with a notified body and executes another contract with another notified body regarding the conformity assessment of the same devices.
- Temporary extraordinary measures specified under the Circular does not apply to unannounced inspections or special inspections that require on-site assessment. However, pursuant to the Circular, notified bodies may apply the extraordinary measures specified under the Circular on a case-by-case basis, especially for inspections regarding medical devices that are clinically needed during COVID-19 restrictions by assessing which alternative emergency measure is most appropriate.
Besides the extraordinary measures that may be taken regarding responsibilities and duties of notified bodies mentioned above, the notified bodies should also carefully follow other guidelines published by TITCK and the EU Commission during COVID-19 pandemic and apply the requirements and principles specified in these documents.
Simge Kılıç, Eda Kurt