Have you documented your strategy for regulatory compliance?

New requirement of the regulations for devices is also a key element of planning your transition

A new requirement for a manufacturer of medical devices and In Vitro Diagnostics (IVDs) is to have a strategy for regulatory compliance. This is listed in Article 10 of the Medical Devices Regulation (MDR) and IVD Regulation (IVDR), where the general obligations of manufacturers are detailed. Paragraph 9 of Article 10 lists the aspects to be addressed by the Quality Management System (QMS) and this includes ‘a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system’.

Article 10 does not provide any further details on the content of this strategy. Annex IX on conformity assessment, however, does add some further information. It indicates that the strategy for regulatory compliance should include the processes for:

• identifying the legal requirements that are applicable,
• qualifying devices against the applicable regulatory requirements,
• handling equivalence to existing devices, and
• choosing the conformity assessment procedures to be used and complying with them.

Furthermore, the strategy for regulatory compliance could be a place to define how you will address:

• implementing requirements for the person responsible for regulatory compliance,
• applying harmonised standards and common specifications,
• managing relationships with other economic operators in the supply chain, including the authorised representative and importer for manufacturers located outside the EU, and
• communicating with your Competent Authority and Notified Body.

ISO 13485:2016, the standard on a QMS for regulatory purposes for medical devices, does not explicitly include a requirement for a strategy for regulatory compliance. But it includes requirements to incorporate regulatory requirements in the QMS on 37 occasions. Additionally, the latest edition of ISO 13485 has a new requirement for the QMS to establish, document, implement and maintain the role of the organization under the regulatory requirements that apply to it. The strategy for regulatory compliance would seem to be the obvious place to document the regulatory role or roles of your organization.

The strategy for regulatory compliance is part of the QMS. Just like all other QMS processes, it has to be:

• established (i.e. defined in sufficient detail),
• documented (i.e. written in a controlled document),
• implemented (i.e. put into effect), and
• maintained (i.e. kept up to date).

As well as being a regulatory requirement, establishing the strategy for regulatory compliance is a key output of the planning to transition to the MDR and IVDR. There are a number of resources available to help with transition planning, including MHRA’s Introductory Guide to new medical device regulations, MedTech Europe’s flowcharts of the regulations andBSI’s free white papers and Compliance Navigator.

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.