EMERGO SUMMARY OF KEY POINTS:
l Russian regulators have finally issued official requirements for medical device and IVD technical file submissions.
l The new rules mostly codify existing requirements that Roszdravnadzor had not previously made official.
l Minor new rules regarding technical file and instructions for use contents have been included in the new order.
The Russian Ministry of Health has issued a new regulation to explain longstanding but unofficial technical file and instructions for use requirements for medical device and IVD registrants.
The new regulation, Order #11N (link in Russian), mostly clarifies existing requirements from Russian medical device regulator Roszdravnadzor; however, the regulator has never officially published these requirements until now, according to Emergo sources in Moscow.
Roszdravnadzor technical file requirements explained
Again, Roszdravnadzor registrants should already be familiar with most of Order #11N’s contents, but the official order should help reduce any confusion and ambiguity regarding proper compliance.
Among technical file requirements previously not explicitly noted by Russian regulators are:
l A list of risks identified during device’s risk analysis process, as well as recommendations to manage and reduce these risks
l Data regarding design, development and validation of any software used as part of a finished device
l Information on the nature and distribution of any radiation emitted by a device, as well as on methods to protect patients and users from any unintended radiation from the device
In addition, Order #11N does include some minor new requirements of which medical device and IVD manufacturers should be aware:
l Links to any previous modifications as well as technical data of a medical device currently registered with Roszdravnadzor whose design has been improved
l Information pertaining to installation and commissioning of a device, as well as suitable premises and necessary training for proper operation of the device
l Information regarding when consumers of a device should consult medical professionals
l Information on the initial release or latest revision to a device’s operational documentation
Russian medical device and IVD market registrants had already been providing most of this technical information before issuance of the new order, so Roszdravnadzor’s latest move should not cause any drastic changes for technical file compliance.
