October 14 ,2013 | By Anabela Farrica
Health technologies can be divided in two main categories: medicines and medical devices. A lot has already been said and written about medicines, but medical devices seem to be out of the public eye most of the time. As a consequence, many raise the question: what is, in reality, a medical device?
Let’s look at the following options:
a) surgical equipment
b) in vitro diagnostic products
c) electronic machinery, such as X-ray machines, ultrasound products and others
d) all of the above
If you answered a), b) or c), you’re not exactly wrong. But you’re not completely right either. Option d) is the most right alternative, but the term “medical devices” can be applied to a much wider range of technologies that the ones listed in options a), b) and c).
Understanding what type of equipment is or is not a medical device can be challenging, but 93/42/EEC Directive provides clarification on this matter. According to this directive, a medical device is: “Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap,
- Investigation, replacement or modification of the anatomy or of a physiological process, or
- Control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”.
A key aspect of the medical devices industry is the variety of products that fall into the above definition. In one end of the spectrum, we have highly complex and invasive products that are associated with a significant degree of risk for the patient. These include the products known as active implantable medical devices, such as pacemakers, cochlear implants and neurostimulators. In the other end of the spectrum, we have relatively simple products such as band-aids, condoms and disposable surgical equipment. Diagnostic equipment, such as ECG monitors are considered medical devices too and are covered by the same regulatory framework. Drug-delivery systems are also medical devices. Due to the wide variety of medical devices, these products are regulated on a risk-based classification system (the rule of thumb being, the higher the risk, the higher the medical device classification). The manufacturer must classify their products according to the set of rules and criteria set out in each region’s relevant medical device regulations.
In comparison with the European legislation for medicines, which has been a subject for discussion for half a century, the directives that regulate medical devices in the EU are fairly recent. Laws in Europe that were specific to Medical Devices before the 1950’s were few and far between, while regulations for medicines were starting to become more and more common, especially after the creation of the Nuremberg Code in 1947. The lack of specific regulation for medical devices was because it was felt that there were few devices that offered an appreciable risk to the patients. The core legal framework consists of 3 directives: Directive 90/385/EEC (and its amending directive, 2007/47/EC), regarding active implantable medical devices; Directive 93/42/EEC regarding medical devices; and Directive 93/87/EC regarding in vitro diagnostic medical devices. These directives are supported by a set of guidance documents, namely MEDDEV and a number of consensus statements and interpretative documents that aim at ensuring uniform application of the legislation within the EU.
One of the major differences between medicines and medical devices lies, however, in their clinical research activities. The development process of pharmaceutical products is traditionally based on a sequential group of trials(the standard Phase I, Phase II and Phase III), during which the safety and efficacy of the product is evaluated. In contrast, medical devices are assessed in terms of their performance and safety requirements. Morevoer, clinical investigation with medical devices needs to focus on the mechanical, electrical and material engineering principles that more often than not underlie such health technologies. Let’s not also forget about the fact that with the rapid change in technology and the increasing development of new materials and new mechanisms of action targeting new indications, conducting good quality clinical research within this industry is a basic demanding.
Clinical investigation of medical devices is essential, as it provides the necessary evidence of the product’s conformity with the Essential Requirements. All the relevant technical documentation containing such data must be submitted to a Notified Body, which is responsible for evaluating this data. Upon a Notified Body’s positive assessment, the manufacturer receives authorization to place the medical device on the market (alongside an authorization to place a CE mark on his product) and the post-marketing surveillance period begins, similar to what happens after a pharmaceutical company is granted a marketing-authorization.
So, much like drugs, medical devices play a crucial role in the diagnosis, prevention, monitoring and treatment of diseases and both are essential health technologies. Drugs are chemical in nature. Devices have mainly a mechanical functioning and do not interfere with as many physiological processes as drugs. There is also a significant difference in numbers and uses. More than 500,000 different types of medical devices are produced worldwide – compared to “only” 20,000 medicinal products. R&D models also vary greatly: driven by technology, device improvements are typically available to users and patients within 18-24 months; medicinal products on the other hand, take about 10-15 years to be available to patients. The device industry is growing and developing at a fast pace. Pharmupdates will now start to cover the most important topics related to medical devices and technologies!
Anabela Farrica is currently first year student of the Master’s Degree course in Pharmaceutical Medicine of the University of Aveiro. She has a BSc in Biomedical Sciences (minor in Pharmaceutical Medicine) from the same University.
She has a personall interest in medical devices and will be contributing on Pharmupdates with news about this industry’s trends and scientific developments.
You can find her contact information below:
– E-mail: firstname.lastname@example.org
– LinkedIn profile: http://www.linkedin.com/profile/view?id=251231239&trk=nav_responsive_tab_profile
And you can find her CV here: Curriculum Vitae – Anabela Farrica