A new mandatory role
to comply with the MDR and IVDR.
The “person responsible for regulatory compliance” is a new mandatory role to comply with the MDR and IVDR.
In order to sell products on the EU market, medical device and/or IVD manufacturers should officially designate a “person responsible for regulatory compliance” (PRRC). This is a new mandatory role for compliance 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.
Therefore, they could choose to outsource the service, for example to our Qarad experts.
The PRRC 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.
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.
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.
Qarad’s experts can act as your outsourced PRRC, helping your company comply with EU regulations for medical devices and IVDs.
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 Qarad PRRC is well structured and is based on the intensive involvement of the Qarad designated person for the PRRC service in the company’s processes.