Some of the most interesting answers in the document are:

Q&A I.6

“Pre-certification services are not allowed before an application is lodged by the manufacturer (e.g. review of clinical data or assessment of the quality management system aside from regulatory standards such as ISO 13485) and therefore these services have to take place under the scope of the application. Every activity carried out once an application has been submitted will be considered part of the conformity assessment activities… Services provided by the conformity assessment body that could fall under the definition of conformity assessment activities are not allowed outside of an application as they would be regarded as consultancy (e.g. gap analysis, check of MDR/IVDR readiness, use of mock-up files produced instead of “real” TD assessments).”

Q&A I.7

“… applications under the MDR / IVDR cannot be accepted (by the conformity assessment body) before the designation of the conformity assessment body became valid, i.e. the day after the notification is published in NANDO.”

Q&A I.9

“Any involvement in processes (e.g. design, risk management, manufacturing processes) being related with the devices and quality management systems for economic operators covered by the application/designation needs to be seen as consultancy. Other activities not specifically linked with the product will be also regarded as consultancy (e.g. internal audits to manufacturers or client specific training).”

Q&A IV.1:

“…all devices to be certified under the MDR / IVDR should be subject to an initial certification according to the applicable annex. The notified body should ensure that all requirements under the MDR / IVDR are fulfilled. It may not restrict its procedures to gap audits or gap file reviews.”

Q&A IV.5

“The MDR / IVDR does not distinguish between Own Brand Label (OBL) manufacturer and other manufacturers. There are just "manufacturers" and therefore OBL manufacturers must comply with the legal requirements, as any other manufacturer. Including but not limited to having: full and permanent access to the technical documentation; (ability for) post-market surveillance including post market clinical follow-up; sufficient technical competence; and control of the quality system (control of the design, manufacture and/or final verification and testing of the devices).”

Q&A V.2

“Whenever the Regulations require certain information to be made “publicly available”, that implies that a member of the public can access this information at any point in time, without the need for additional steps.”

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.


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ISO 13485 and ISO 27001


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