Article 15 of the MDR/IVDR: Person Responsible for Regulatory Compliance (PRRC) – Summary Guidance Statement.
We have heard numerous stories from around the world containing mixed messages regarding who can be appointed the PRRC of a medical device manufacturer. The following will hopefully answer the basics and we will try to keep this short and to the point. Does a manufacture need to appoint a PRRC? Yes, all manufacturers must ...
MDCG 2019-07 Rev.1 Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)
The MDCG has updated a guidance document, initially published in 2019 regarding article 15 of the MDR and IVDR concerning the Person Responsible for Regulatory Compliance, commonly abbreviated to PRRC. Among the plethora of updates that have been introduced in the guidance document, most notably, the new updated guidance document sees the following updates: The ...
Person Responsible for Regulatory Compliance (PRRC)
Article 15 of both the in vitro diagnostic medical device regulation (2017/746) and the medical device regulation (2017/745) describe the new obligation that manufacturers and authorised representatives must meet such that they must have at least one Person Responsible for Regulatory Compliance (PRRC) “available within their organisation”. Manufacturers and authorised representatives must demonstrate that the ...
