Medical Devices

The term “medical device” covers a wide range of products, from consumables (syringes, catheters, guidewiress, needles, etc.) to heavy equipment such as CT scanners and MRI machines, as well as dressings and active or non-active implantable devices (pacemakers/defibrillators, orthopedic prostheses, etc.), software used for medical purposes, and in-vitro diagnostic devices.

In the European Union :

The European market regulates access to medical devices through two regulations:

• Regulation (EU) 2017/745 on medical devices (MDs),
• Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVD MDs).

These two regulations set out the requirements applicable to manufacturers in terms of demonstrating the conformity of their devices to safety and performance requirements, particularly the clinical ones.

The two regulations divide devices into different classes, depending on their intended use and the potential risks associated with their use or design. Access to the European market varies according to the class of the device. The higher the class, the greater the involvement of a notified body.

The manufacturer is legally responsible for placing devices on the market that complies with the applicable requirements and bear CE Mark. It is the manufacturer’s responsibility to establish the elements demonstrating this conformity, and to take the necessary steps, with the involvement of a notified body where necessary.

In the USA :

In the US, the access to the market for medical devices is also regulated. The applicable requirements are described in regulations (21 CFR) and guidance documents.

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type.

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

• Establishment registration (21CFR Part 807)
• Medical Device Listing (21CFR Part 807)
• Premarket Notification 510(k), unless exempt, (21CFR Part 807 Subpart E) or Premarket Approval (PMA) (21CFR Part 814)
• Investigational Device Exemption (IDE) for clinical studies (21CFR Part 812)
• Quality System (QS) regulation (21CFR Part 820)
• Labeling requirements (21CFR Part 801), and
• Medical Device Reporting (21CFR Part 803)

The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.