Does your person responsible for regulatory compliance meet the required criteria?

Guidance on Article 15 of the Regulations issued by the European Commission

Article 15 of both the Medical Device Regulations and the In Vitro Medical Device (IVD) Regulations have requirements for appointing a ‘person responsible for regulatory compliance’ (PRRC). Manufacturers and Authorised Representatives (AR) for both medical devices and IVDs have to identify at least one PRRC.  The Medical Device Coordination Group has recently endorsed and made available guidance on this topic. It should be noted that a disclaimer on the document indicates that it is not legally binding.

This PRRC has to meet minimum requirements for qualification and experience. The criteria are:

• evidence of formal qualification on completion of a university degree or equivalent, in law, medicine, pharmacy, engineering or another 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 (QMS) relating to medical devices

The recent guidance clarifies that:

• any qualification acquired outside the EU should be recognized as equivalent to the EU corresponding qualification
• professional experience in regulatory affairs or in QMS should be related to the EU requirements for medical devices

For a manufacturer, the PRRC needs to be within their organization. The recent guidance clarifies that this means that they need to be an employee of the manufacturer. The guidance also indicates that organisations with more than one manufacturer under the parent company would need to ensure that each manufacturer has its own PRRC.

An exception is an organization that meets the official definition of a “micro” or “small” manufacturer.  These are defined as employing fewer than 50 staff and not exceeding EUR 10 million in annual turnover and/or annual balance sheet total.  While the PRRC does not have to be within the organization of such micro or small manufacturers, they have to be permanently and continuously available. Equally, the PRRC in the AR does not have to be within their organization but similarly has to be available to them all the time. Therefore, micro and small manufacturers or AR can use external resources to meet this requirement. The recent guidance clarifies that, for micro or small manufacturers located in the EU and for ARs, the PRRC should be also located in the EU in order to be permanently and continuously at their disposal.

The guidance also indicates that there is a clear desire within the Regulations for the AR to:

• add an additional level of scrutiny
• ensure the supervision and control of the manufacture of devices
• ensure implementation of post-market surveillance and vigilance activities

The guidance indicates that, this additional level of scrutiny would be undermined if the role of PRRC in the manufacturer and AR were combined. Therefore:

• the PRRC for an AR and a manufacturer located outside the EU cannot be the same person
• the PRRC of a micro or small enterprise and the PRRC of the AR of that same enterprise cannot belong to the same external organisation

The responsibilities of the PRRC cover ensuring:

• conformity of the device is checked in accordance with the quality management system before release
• regulatory documentation is prepared and maintained
• post-market surveillance obligations are met
• requirements for submission of vigilance reports are complied with
• compliance of devices used for clinical investigation is documented

The guidance does not provide any further interpretation of the roles and responsibilities of a PRRC. It recommends that any guidance on post-market surveillance, vigilance, clinical investigations and performance studies at a European level should provide guidance on what a PRRC would be expected to do in these areas. A previous blog on this topic includes some additional information. BSI’s Compliance Navigator can also help you understand the requirements.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development