Ensuring EU regulatory compliance through the Person Responsible for Regulatory Compliance (PRRC)
The Medical Device Regulation (MDR), replaced the existing Medical Device Directive (MDD) ON 26.5.21
According to the MDR, Manufacturers are obligated to have at least one person responsible for regulatory compliance (PRRC) who possesses the requisite expertise in the field of medical devices.
Have you designated a PRRC?
What are the PRRC responsibilities?
The PRRC is responsible to ensure that the manufacturer will comply with at least the following requirements:
-
Ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
-
Ensuring the EU Declaration of Conformity is drawn up and kept up-to-date;
-
Ensuring compliance with post-market surveillance obligations (Article 10);
-
Ensuring reporting obligations referred to in Articles 87 to 91 are fulfilled;
Who can be PRRC?
The MDR defines the requisite expertise as having one of the 2 options below:
-
A diploma, certificate or other evidence of formal qualification awarded on completion of a university degree in a relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
-
Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Designate outsourced PRRC
The PRRC role must be in house according the Medical Device Regulations (MDR/IVDR) except in the case of Micro & Small Enterprises in which case the PRRC role may be outsourced. The PRRC must meet the required qualifications and shall be permanently and continuously at those Enterprises disposal.
SYNC Projects experience allows us to offer our services as:
1. outsourced person responsible for regulatory compliance (PRRC) for micro & small companies.
2. outsourced consultant to support the PRRC in your organization.
We will Provide you with a comprehensive professional answers, on quality and regulatory issues of MDR and the required compliance with the European market (including the UK), we will act and carry out the PRRC tasks for the benefit of the organization's compliance with European regulatory guidelines, And of course Make sure to be available to you and respond to any issue in shortest time as possible (no later than 24 hours).
How can we help you?
We Provide close and available guidance to any subject in the shortest time as possible.
We provide full transparency to all interested parties and invite you to visit us at any time.
We have 20 years of business experience with
a professional and reliable reputation in the field.
The company's services are performed by a skilled team, in order to provide fast and efficient service to all our customers.
We will be happy to assist with any question and request
For more information about PRRC
Fill in your details and we will contact you shortly
