Medical Device Regulations (MDR) Classifications: US vs EU

Manufacture automated-1

In this post, 2 of 4, we’ll consider the Classification of Medical Devices in the EU versus USA


In the other parts of this Post we have …

Definition, Classification and Regulation of Medical Devices (1 of 4)

        • Definitions of Medical Devices - ISO 13485 vs. EU versus USA

Definition, Classification and Regulation of Medical Devices (3 of 4)

        • Medical Device Regulations in the EU (EMA)
        • Medical Device Regulations in the UK (MHRA).

Definition, Classification and Regulation of Medical Devices (4 of 4)

        • The Medical Device Regulations of the United States (FDA)
        • The Medical Device Regulations of the MDSAP Countries
        • The Medical Device Regulations of the Rest of the World (WHO)

Classification of Medical Devices

The regulatory authorities recognize different classes of medical devices, based on their design complexity, their use characteristics, and their potential for harm if misused.

Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in combination with drugs, and regulation of these combination products takes this factor into consideration.

Classification of Medical Devices in the United States

The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892. The suggested starting point in classifying a medical device is to search the FDA Product Classification Database to determine if there is an existing product classification that applies to your product.

In general terms, the Food and Drug Administration has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device.

Class I Medical Devices: General Controls

Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. These devices are subject only to general controls.

General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labelling, notification of the FDA before marketing the device, and general reporting procedures. (Most Class I devices are exempt from the good manufacturing practices and/or the FDA notification regulations.)

These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage.

Examples of Class I Medical Devices

Devices in this category include tongue depressors, bedpans, elastic bandages, most hand-held dental instruments, examination gloves, and hand-held surgical instruments and other similar types of common equipment.

Depending on the "stated/purported use" of a device, it may be necessary to obtain a Premarket Approval or 510K for the device, which is otherwise classifiable as a Class 1 device. Such devices are referred to as "reserved devices". The electrically-powered arthroscope (which is really an endoscope powered electrically) is a case in point.

While endoscopes are Class 1 devices, the electrically-powered arthroscopes need a pre-market notification (510K) although the manual arthroscopes do not. Pre-market notified devices are marketed as "at least as safe and effective, that is, substantially equivalent, to a legally marketed device."Gap Analysis ISO 13485

Class II: General Controls with Special Controls

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances.

Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and post-market surveillance.

Devices in Class II are held to a higher level of assurance than Class I devices and are designed to perform as indicated without causing injury or harm to the patient or user.

Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material, acupuncture needles.

Class III: General Controls and Premarket Approval

A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices.

Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I.

Class III devices are described as those for which "insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."

Examples of Class III devices that require premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generators, and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which are reclassified as Class II).

A description of device classification and a link to the Product Classification Database is available at "Classification of Medical Devices."

European Union (EU) and European Free Trade Association (EFTA)

The classification of medical devices in the European Union is given in Annex VIII of the Regulation (EU) 2017/745.

Devices are divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. There are basically four classes, ranging from low risk to high risk.

  • Class I (including Is & Im)
  • Class IIa
  • Class IIb
  • Class III

The authorization of medical devices is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer itself, but for products in Class Is, Im, IIa, IIb or III, it must be verified by a Certificate of Conformity issued by a Notified Body.

A Notified Body is a public or private organisation that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not need to be sterilised or are not used to measure a function) can be put on the market purely by self-certification by the manufacturer.

The European classification depends on rules that involve the medical device's duration of body contact, its invasive character, its use of an energy source, its effect on the central circulation or nervous system, its diagnostic impact or its incorporation of a medicinal product.

Certified medical devices should have the CE mark on the packaging, insert leaflets, etc. The packaging should also show harmonised pictograms and EN standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don't reuse, etc.

The classification of in vitro diagnostic medical devices in the European Union is given in Annex VIII of the Regulation (EU) 2017/746.

IVD devices are divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks. Classification is carried out in accordance with Annex VIII of IDVR.

 

Three levels of ISO 13485 Auditor Training - Interlan Auditor, Lead Auditor & Lead Implementer

 

It's complicated!

As we’ve said previously applicable definitions, classification and regulation varies with location and, while there is a drive towards a uniform global system, we’re not there yet. Consequently, we’ll examine the situation in a series of 4 posts, namely,

  1. Definition of medical devices, ISO 13485 vs EU vs USA
  2. Classification of Medical Devices, EU vs USA
  3. Regulatory Regimes, EU, UK
  4. Regulatory Regimes, USA, MDSAP Countries and Rest of the World.

 

Choose an ISO 13485 Course

 

Written by Dr John FitzGerald

Director & Founder of deGRANDSON Global. Spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems

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