As the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) continue to evolve, one requirement is getting a lot of attention – the person responsible for regulatory compliance (PRRC). This individual (or individuals) is one of the newly introduced requirements of the MDR/IVDR and their presence is to ensure that companies have a qualified regulatory expert at their disposal. If a company consists of more than one legal manufacturer, each legal manufacturer must appoint its own PRRC.
What are the MDR/IVDR responsibilities of a PRRC? There are several major ones, with slight variations between the MDR and IVDR:
- Checking the conformity of devices in accordance with the quality management system under which the devices are manufactured, before a device is released to ensure medical device compliance
- Drawing up and maintaining the technical documentation and the EU declaration of conformity
- Complying with the post-market surveillance obligations in accordance with Article 10(10)
- Fulfilling vigilance reporting obligations, such as serious incidents, field safety corrective actions, and incident trend reporting
- Issuing statements confirming that investigational devices conform to the General Safety and Performance Requirements of the EU MDR/IVDR
The new role of the PRRC adds an additional level of scrutiny for medical devices and ensures that mandatory activities related to the supervision and control of manufacturing, post-market surveillance, and vigilance are carried out appropriately.
Does the PRRC need to be a company employee?
The short answer is no. Larger enterprises with over 50 employees and annual revenue over 10 million Euros must have a PRRC on staff. However, small-to-medium-sized businesses (SMBs) and medical device start-ups with fewer than 50 employees can use third-party regulatory consulting experts (such as MEDIcept) if the PRRC meets qualification criteria and is permanently and continuously at the company’s disposal (however, the regulations are currently fairly vague regarding the practical implications of permanent and continuous availability).
To learn more about the proper approach for retaining a PRRC at your firm and the most cost-efficient and effective way to do so, contact the EU regulatory experts here at MEDIcept.
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MEDIcept Inc. is an international consulting firm specializing in medical device, IVD, and biotechnology Regulatory, Quality, and Clinical Services. Since 1996, we have worked with thousands of companies to solve their most critical FDA and ISO issues. Our integrated solutions are rooted in our direct experience and span all stages of the product life.
Our staff includes former FDA and ISO personnel and industry experts with an in-depth functional knowledge of medical devices. Medical device compliance requires the navigation of a maze of requirements. MEDIcept can interpret FDA regulations, guidance documents, and ISO standards and provide clients with the information they need to comply in a safe and cost-effective manner.
MEDIcept is committed to providing our clients with what they need. We are committed to quality deliverables because we value our clients’ time and resources. This is why 90% of our clients come back to us again and again to solve new issues.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.