Regulatory Open Forum

For a medicinal/device combination product in the EU, if the action of a medicinal substance is primary and not ancillary to that of the device, the integral medicinal/device combination product shall be regulated by the Directive for Medicinal Products For Human Use (2001/83/EC). If the device component of a medicinal/ device combination product has not previously been issued a CE mark under the MDR, what is the procedure for a manufacturer to seek a NB Opinion (NBo) on the conformity of the device to the general safety and performance requirements set out in Annex I of the MDR in order that the NB can subsequently issue a NBo Report for inclusion in the Marketing Authorization Application(MAA) for the medicinal component of the medicinal/device combination product (Ref: MDR Article 117, Amendment to Directive 2001/83/EC, second paragraph)?

Subsequently, does the post market surveillance requirements fall under the medicinal Pharmacovigilance system requirements (e.g., PSUR, medical literature monitoring, reporting of adverse events, etc.) or should the Technical Documentation of the device component contain the Post Marketing Surveillance (PMS) documents required by the MDR.

Thanks in advance for your comments,

For a medicinal/device combination product in the EU, if the action of a medicinal substance is primary and not ancillary to that of the device, the integral medicinal/device combination product shall be regulated by the Directive for Medicinal Products For Human Use (2001/83/EC). If the device component of a medicinal/ device combination product has not previously been issued a CE mark under the MDR, what is the procedure for a manufacturer to seek a NB Opinion (NBo) on the conformity of the device to the general safety and performance requirements set out in Annex I of the MDR in order that the NB can subsequently issue a NBo Report for inclusion in the Marketing Authorization Application(MAA) for the medicinal component of the medicinal/device combination product (Ref: MDR Article 117, Amendment to Directive 2001/83/EC, second paragraph)?

Subsequently, does the post market surveillance requirements fall under the medicinal Pharmacovigilance system requirements (e.g., PSUR, medical literature monitoring, reporting of adverse events, etc.) or should the Technical Documentation of the device component contain the Post Marketing Surveillance (PMS) documents required by the MDR.

Thanks in advance for your comments,

For a medicinal/device combination product in the EU, if the action of a medicinal substance is primary and not ancillary to that of the device, the integral medicinal/device combination product shall be regulated by the Directive for Medicinal Products For Human Use (2001/83/EC). If the device component of a medicinal/ device combination product has not previously been issued a CE mark under the MDR, what is the procedure for a manufacturer to seek a NB Opinion (NBo) on the conformity of the device to the general safety and performance requirements set out in Annex I of the MDR in order that the NB can subsequently issue a NBo Report for inclusion in the Marketing Authorization Application(MAA) for the medicinal component of the medicinal/device combination product (Ref: MDR Article 117, Amendment to Directive 2001/83/EC, second paragraph)?

Subsequently, does the post market surveillance requirements fall under the medicinal Pharmacovigilance system requirements (e.g., PSUR, medical literature monitoring, reporting of adverse events, etc.) or should the Technical Documentation of the device component contain the Post Marketing Surveillance (PMS) documents required by the MDR.

Thanks in advance for your comments,

For a medicinal/device combination product in the EU, if the action of a medicinal substance is primary and not ancillary to that of the device, the integral medicinal/device combination product shall be regulated by the Directive for Medicinal Products For Human Use (2001/83/EC). If the device component of a medicinal/ device combination product has not previously been issued a CE mark under the MDR, what is the procedure for a manufacturer to seek a NB Opinion (NBo) on the conformity of the device to the general safety and performance requirements set out in Annex I of the MDR in order that the NB can subsequently issue a NBo Report for inclusion in the Marketing Authorization Application(MAA) for the medicinal component of the medicinal/device combination product (Ref: MDR Article 117, Amendment to Directive 2001/83/EC, second paragraph)?

Subsequently, does the post market surveillance requirements fall under the medicinal Pharmacovigilance system requirements (e.g., PSUR, medical literature monitoring, reporting of adverse events, etc.) or should the Technical Documentation of the device component contain the Post Marketing Surveillance (PMS) documents required by the MDR.

Thanks in advance for your comments,

For a medicinal/device combination product in the EU, if the action of a medicinal substance is primary and not ancillary to that of the device, the integral medicinal/device combination product shall be regulated by the Directive for Medicinal Products For Human Use (2001/83/EC). If the device component of a medicinal/ device combination product has not previously been issued a CE mark under the MDR, what is the procedure for a manufacturer to seek a NB Opinion (NBo) on the conformity of the device to the general safety and performance requirements set out in Annex I of the MDR in order that the NB can subsequently issue a NBo Report for inclusion in the Marketing Authorization Application(MAA) for the medicinal component of the medicinal/device combination product (Ref: MDR Article 117, Amendment to Directive 2001/83/EC, second paragraph)?

Subsequently, does the post market surveillance requirements fall under the medicinal Pharmacovigilance system requirements (e.g., PSUR, medical literature monitoring, reporting of adverse events, etc.) or should the Technical Documentation of the device component contain the Post Marketing Surveillance (PMS) documents required by the MDR.

Thanks in advance for your comments,

For a medicinal/device combination product in the EU, if the action of a medicinal substance is primary and not ancillary to that of the device, the integral medicinal/device combination product shall be regulated by the Directive for Medicinal Products For Human Use (2001/83/EC). If the device component of a medicinal/ device combination product has not previously been issued a CE mark under the MDR, what is the procedure for a manufacturer to seek a NB Opinion (NBo) on the conformity of the device to the general safety and performance requirements set out in Annex I of the MDR in order that the NB can subsequently issue a NBo Report for inclusion in the Marketing Authorization Application(MAA) for the medicinal component of the medicinal/device combination product (Ref: MDR Article 117, Amendment to Directive 2001/83/EC, second paragraph)?

Subsequently, does the post market surveillance requirements fall under the medicinal Pharmacovigilance system requirements (e.g., PSUR, medical literature monitoring, reporting of adverse events, etc.) or should the Technical Documentation of the device component contain the Post Marketing Surveillance (PMS) documents required by the MDR.

Thanks in advance for your comments,