MDR: Per­son Respon­si­ble for Regu­la­to­ry Affairs

Artic­le 15 of the MDR defi­nes requi­re­ments for the “per­son respon­si­ble for regu­la­to­ry com­pli­ance” (PRRC), spe­ci­fy­ing that manu­fac­tu­r­ers of medi­cal devices must have at least one per­son “within their orga­niza­ti­on” who “pos­s­es­ses the requi­si­te exper­ti­se in the field of medi­cal devices.”

The PRRC is “more” than just a “Safe­ty Offi­cer 2.0.” The PRRC’s respon­si­bi­li­ties for ensu­ring com­pli­ance with regu­la­ti­ons go far bey­ond the duties of a safe­ty offi­cer

The gui­dance docu­ment MDCG 2019–7 Gui­dance on Artic­le 15 of the Medi­cal Device Regu­la­ti­on (MDR) and In-vitro Dia­gno­stic Device Regu­la­ti­on (IVDR) regar­ding a “per­son respon­si­ble for regu­la­to­ry com­pli­ance” (PRRC) con­ta­ins an in-depth dis­cus­sion of Artic­le 15 of the MDR and the defi­ni­ti­on of “orga­niza­ti­on.”

The gui­dance docu­ment sta­tes as follows:

“The per­son respon­si­ble for regu­la­to­ry com­pli­ance (PRRC) appoin­ted would need to be an employee of the orga­niza­ti­on. Orga­niza­ti­ons with more than one legal manu­fac­tu­rer under the parent com­pa­ny would need to ensu­re that each legal manu­fac­tu­rer has its own PRRC.”

The requi­re­ment estab­lished by Artic­le 15 of the MDR to have at least one PRRC available within the orga­niza­ti­on appli­es to each indi­vi­du­al “legal manu­fac­tu­rer.” In accordance with Artic­le 2 No. 30 of the MDR, a “manu­fac­tu­rer” is a “natu­ral or legal per­son who manu­fac­tu­r­ers or ful­ly refur­bis­hes a device or has a device desi­gned, manu­fac­tu­red or ful­ly refur­bis­hed, and mar­kets that device under its name or trademark.”

Accor­din­gly, in cases whe­re the same cor­po­ra­te struc­tu­re includes mul­ti­ple manu­fac­tu­r­ers as defi­ned in Artic­le 2 No. 30 of the MDR, each of the­se manu­fac­tu­r­ers would have to have its own PRRC available within its organization.


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