Have you identified your person responsible for regulatory compliance?

Medical device and IVD regulations have specific responsibilities for this new role at manufacturers and Authorised Representatives

Article 15 of both the Medical Device Regulations and the In Vitro Medical Device Regulations have significant new requirements for appointing a ‘person responsible for regulatory compliance’. Manufacturers and Authorised Representatives (AR) for both medical devices and IVDs have to identify at least one such person.  This person responsible for regulatory compliance has to meet minimum requirements for qualification and experience. Their responsibilities cover ensuring:

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

The responsibilities can be divided between more than one person provided that the responsibility of each individual is defined and all responsibilities are covered. For a large organization, these responsibilities are likely to reside with individuals in different functions in the organizational structure.

The name and work address of the person or persons responsible for regulatory compliance have to be included with the registration of the manufacturer or AR. The information has to be kept up to date when changes are made.

For a manufacturer, the person(s) responsible for regulatory compliance has to be available within their organization. This means that they should be an employee of the manufacturer. An exception is an organization that meets the official definition of a “micro” or “small” manufacturer. While the person responsible for regulatory compliance does not have to be within the organization of such micro or small manufacturers, the person has to be permanently and continuously available. Equally, the person responsible for regulatory compliance 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 person responsible for regulatory compliance should not be financially or professionally disadvantaged for properly fulfilling their duties, whether or not they are employees of the organisation or are contracted to it.

It might appear that there is plenty of time to implement these changes. They apply to all devices at the end of the transition periods or when CE marking a device to the applicable Regulation if done sooner. But given the change involved, and the need to integrate the person responsible for regulatory compliance into your QMS, it is advisable you start identifying the role or roles that will take on these responsibilities as soon as possible. This will allow you to understand fully the effect on your internal processes and accommodate external factors outside your direct control. BSI’s Compliance Navigator can 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.