Person Responsible for Regulatory Compliance (PRRC)
Are you looking for a person responsible for regulatory compliance (PRRC)Â for your medical devices and/or IVDs?Â
QbD Group provides PRRC services to MD and/or IVD manufacturers with fewer than 50 employees who do not have an internally qualified RAQS position.Â
Manufacturers located outside the EEA are also required to confirm that their EU authorised representative has appointed a PRRC, our QbD IVD/Qarad experts can also provide this service. Â
We can help you meet this EU regulatory requirement. More information about our PRRC service can be found below.Â
Part of the QbD Group
IVD PRRC service is supported by Qarad
What is a Person Responsible for Regulatory Compliance (PRRC)?
In order to sell products on the EU market, medical device and/or IVD manufacturers should officially designate a PRRC. The “person responsible for regulatory compliance” is a new mandatory role to comply with the MDR and IVDR.
If a medical device and/or IVD manufacturer does not have an officially designated PRRC, the company cannot sell its product in the EU market.
Small and micro companies (with fewer than 50 employees and an annual turnover and/or balance sheet <10M Euros) may choose to hire a qualified RAQS resource for this purpose. However, qualified RAQS resources are often difficult to find and/or very expensive.Â
Therefore, they could also choose to outsource the service, for example to our QbD experts.Â
The “person responsible for regulatory compliance” must take responsibility for the product compliance before the notified bodies and the competent authorities. To start a PRRC role for a new company, a review of the QMS and all technical documentation of the product is required in advance.Â
In addition, the PRRC must be notified by the company of any announced audit, any QMS or product change, and any complaint, recall, or field safety. This person must be permanently and continuously available to them.
The PRRC of an authorised representative is responsible for ensuring that the tasks of the authorised representative as specified in the mandate with the manufacturer (referred to in Article 11(3) of the Regulations) are fulfilled. This means that the AR’s PRRC is responsible for ensuring whatever tasks the manufacturer and AR have agreed in the mandate have been fulfilled. Â
How can we support you?
- We can act as your PRRC or as PRRC for the Authorised Representative.Â
- Consult on the regulatory requirements on PRRC assigning and tasks.Â
- Assist in writing or reviewing the procedure on PRRC and procedures including PRRC responsibilities.
Why QbD Group?
To ensure easy access to the European market, it is important to choose an experienced person responsible for regulatory compliance (with at least four years of professional experience in regulatory affairs or in quality management systems related to medical devices) who can guide you through the process.
QbD’s experts can act as your outsourced PRRC, helping your company comply with EU regulations for medical device and IVD manufacturers.
With over 20 years of industry experience, we can guarantee you the benefit of an outsourced center of excellence for all quality & regulatory matters, in a cost-effective manner.
Finally, the process for designating a QbD PRRC is well structured and is based on the intensive involvement of the QbD designated person for the PRRC service in the company’s processes.
Contact us
Contact us for more information or to request a free, no-obligation proposal.
