Understanding EU Classification of ‘Active’ Medical Devices

The medical device industry is evolving rapidly with the invention of technological devices which can assist both patients and practitioners. Whether you’re looking for a list of Medical Equipment Companies in UAE, or are just looking at the market in general, it’s imperative to understand the different classifications.

Recent years have seen the need for a new category of medical devices which can be implanted in the human body, and have their own power source. These devices have evolved rapidly since the invention of the first pacemaker back in 1960. We’re also starting to get a glimpse of the future of such devices, with various robotics companies working on bionic limbs.

Here’s an overview of active medical devices, and what we can expect in the years to come.

Active Implantable Medical Devices

Understanding Active Implantable Medical Devices (AIMDs) requires contemplation of a few different factors, including the definition, regulations, and some examples.

Definition

Defined as ‘an active medical device intended to be totally or partially introduced into the human body for diagnostic or therapeutic purposes and is to remain in place’.

Regulations

Due to the nature of AIMDs, there are strict regulations around the production and distribution of them in most developed countries. For the sake of looking at distribution within countries that abide by EU regulations, we’ll consider the international process. As both the EU and Canada have exact facsimiles of the international standards.

IEC 60601

This is the International Electrotechnical Commission’s series of technical standards for the safety and essential performance of medical electrical equipment. It was first published in 1977, and is constantly being updated and restructured.

The current IEC 60601 (Edition 3.1) contains almost 700 entirely new standards since the prior IEC 60601 (Edition 2.2). It has a stronger focus on risk management, and manufacturers must now estimate for each applicable risk, the probability of occurrence and the severity of that risk both before and after risk mitigation measures have been applied.

IEC 60601-1

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

This part of the standard defines medical electrical equipment as electrical equipment having an applied part, or transferring energy to or from the patient or detecting such energy transferrals to or from the patient, which is:

• Provided with no more than one connection to a particular supply mains; and

• Intended by its manufacturer to be used: in the diagnosis, treatment, or monitoring of a patient, or for compensation or alleviation of disease, disability, or injury.

Collateral Standards 60601-1-x

These standards define the requirements for certain aspects of safety and performance, and can be revised separately from the General Standard.

• IEC 60601-1-2 Electromagnetic disturbances - requirements and tests

• IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment

• IEC 60601-1-6 Usability

• IEC 60601-1-8 General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems.

• IEC 60601-1-9 Requirements for environmentally conscious design

• IEC 60601-1-10 Requirements for the development of physiologic closed-loop controllers

• IEC 60601-1-11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

• IEC 60601-1-12 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.

Particular Standards

There are about 80 different particular standards which apply to particular kinds of medical electrical equipment. Check out the IEC 60601 Wikipedia page for a list of the particular standards which may apply to the devices you’re considering.

Examples of AIMDs

As previously mentioned, the pacemaker is the first AIMD and is probably the most well-known of them all. Here are some other examples of common AIMDs:

• Implantable defibrillators and accessories

• Implantable neurostimulator systems and accessories

• Implantable infusion pumps and accessories

• Implantable glucose monitors and accessories

• Ventricular Assist Devices (VADs) and accessories

• Cochlear implants and accessories

• Brachytherapy systems and accessories

• Micro Electro-Mechanical Systems (MEMS)

• Adaptors, leads, and electrodes for implantable pulse generators

The Future of AIMDs

The world of AIMDs is ever-evolving, and with the advent of quantum computing and advancements in 3D printing, we may see some unimaginable concepts come to fruition in the coming years. Here are some examples of AIMDs we may see:

• Commercially-available bionic limbs

• Drug-eluting stents

• Brain-computer Interface Hardware and Software

• Nanobots which can repair such things as cells or remove unwanted viruses or bacteria

It’s fair to say that the future of AIMDs is bright, and holds many things which we may not even be able to perceive at this point in time. Whether you’re working with medical equipment distributors in UAE, or are simply considering entering the AIMDs market, considering these points first will help you in your venture.

If you are looking for a list of Medical Equipment Companies in UAE, then this might help you in your quest.