A major challenge, particularly for manufacturers of medical devices

Regulatory affairs

Regulatory issues are omnipresent in the healthcare industry and at the heart of the life cycle of medical devices. The level of quality and regulatory requirements has increased considerably in recent years.

From design to market launch and post-market monitoring, they represent a major challenge for manufacturers, but often require support to ensure they successfully pass the various stages.

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Issues

Marketing and CE marking

A medical device is an instrument, equipment or software intended for use in humans for the diagnosis, prevention, control or treatment of disease or injury. This definition encompasses several hundred thousand devices of great diversity, from compresses to artificial hearts, including orthopaedic prostheses and pacemakers. Whatever their purpose, whether implantable or not, reusable or single-use, the health authorities’ primary concern is to define the risks that these devices may pose to patients and their families.

In order to be sold on the European market, a medical device must comply with the general safety and performance requirements applicable to it. This is demonstrated by the CE marking.

These requirements vary according to different criteria, including the application of the medical device, its risk class and the country in which it is marketed. There are different regulations around the world, and manufacturers must comply with the regulatory requirements of the region in which the medical device will be marketed:

  • the Food and Drug Administration (FDA) in the United States
  • thePharmaceutical and Medical Devices Agency (PMDA) for Japan,
  • the China Food and Drug Administration (CFDA) for China
  • the Trans Tasman Therapeutic Products Agency (TGA) for Australia and New Zealand.

CE marking, which is a prerequisite for marketing a device, can be a complex and time-consuming process that requires support.

Obtaining cover

Each country is responsible for obtaining reimbursement. Some countries are satisfied with CE marking, while others, such as France, require additional assessment of the device by the health authorities.

In France, the additional assessment required for inclusion in the List of Products and Services (LPP) reimbursable by the health insurance scheme is carried out under the responsibility of the French Health Authority (Haute Autorité de Santé).

Response to the new European regulation

All these steps will be profoundly altered by the new European regulation for medical devices, which is due to be phased in from 2023.

The aim of these new regulations is to strengthen health safety and harmonise the application of rules within the European Union. These changes require a thorough understanding of the regulatory context, as well as experience in setting up a quality management system and, of course, knowledge and expertise in medical device manufacturing processes.

Contribution from TRONICO

In addition to the design and production of medical devices, TRONICO’s expertise in regulatory affairs enables it to assist its customers with the regulatory aspects of their medical devices.

Drawing up a regulatory strategy based on the class and use of the device in the target markets

  • Regulatory compliance (CE marking, international approvals)
  • Implementation of quality management systems
  • Defining strategy and formalising clinical trial applications
  • Formalising clinical evaluation dossiers
  • Monitoring standards and regulations