Digital Therapeutics and Medical Device Regulation: What Evolve for Manufacturers? 


One year ago, the new European Medical Device Regulation (MDR) came into force. MDR requires medical device manufacturers to adapt and implement stricter quality and regulatory processes than its predecessor, the Medical Device Directive (MDD), with the foremost aim of reinforcing patient safety.

In our latest “Meet the Voluntis Team” interview, Anaïs – Voluntis Quality Assurance Regulatory Affairs Manager – discusses what regulators in the European Union now expect from manufacturers, especially in terms of Software as a Medical Device (SaMD) and digital therapeutics (DTx).

Medical Device Regulation Digital Therapeutics

Can you describe your role at Voluntis?

I am responsible for Quality Assurance and Regulatory Affairs (QARA) within Voluntis. My main mission is to ensure that we develop safe and effective medical products in compliance with current applicable regulations, including MDR. To do so, our Quality Management System (QMS) is composed of procedures, work instructions, and forms that outline best practices to manufacture high-quality products that meeting all the standards and requirements for medical devices.

The main objective of the QARA department is to make sure our processes reflect our current practices but also meet regulatory requirements as they continue to change in Europe and around the world. For this reason, the QA team is engaged throughout the product creation cycle and works closely with the project teams to apply processes and determine any need for updates. We value the involvement of all employees in the continuous improvement of our QMS, as it shows that our company takes quality and safety seriously.

MDR became effective last year, in May 2021. What new measures does this regulation impose?

How do these new measures impact manufacturers in practice?

Can you give us a concrete example of what a manufacturer should do regarding post-market surveillance?

Is Voluntis ready for MDR?

If you wish to know more about our quality and regulatory policies, please click here.

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