Healthcare Technologies Resource Guide - Export.gov

Classification
Manufacturers should note that the differences in regulatory approach between the EU and the U.S.
mean differences in classification and compliance verification. It would be wrong to assume that meeting
the requirements for the U.S. market would satisfy the EU requirements. To illustrate this point, hospital
beds including accessories, according to FDA guidance, are either Class I or II depending on the type of
bed. In the EU, hospital beds and accessories are classified as Class I devices, allowing self-certification. In
addition, the beds and their accessories would have to be considered separately, each as medical devices
in their own right, especially when such items are sold separately.
The AIMD directive has one class and does not allow self-certification. The medical device directive
covers four classes, ranging from Class I, II a and b, to Class III. Only Class I devices can be self-certified.
Manufacturers have to involve the services of a notified body in all other cases, and sterile Class I
devices or those with a measuring function must also use a notified body. The IVD does not distinguish
classes, but rather groups: general tests, self-testing kits, and Annex II lists A and B. For simple tests,
self certification is usually an option. To help with classification in case the annexes in EU directives are
difficult to interpret, the Commission has published new guidance at http://bit.ly/PfkVYa.
Borderline Products
For the majority of medical devices, the purpose is obvious: pacemakers, endoscopes, syringes and
wound dressing are clearly to be used for medical purposes. Products where the intended purpose is not
so clear are known as borderline products and they may be subject to several directives. For example,
a scale to weigh patients in a hospital would be subject to both the non-automatic weighing scale and
the medical device directives. Disinfectants for exclusive use with a medical device may be classified
as an accessory to a medical device because the intended purpose is medical rather than general.
The intended purpose is usually supported by appropriate statements on the company’s website or
in promotional literature. It is possible to get an official interpretation to clarify borderline products
but manufacturers should be able to make the determination in most cases themselves by using the
guidance provided by the Commission.
The Commission released new guidance on borderline products in March 2011: bit.ly/QExPo6.
Compliance with “Essential Requirements”
The “essential requirements” for the protection of health, safety and environmental concerns form
the core of the directives. They cover risks and hazards that may occur at the design, production and
handling stages. The manufacturer has to address the essential requirements which apply to a product
and identify relevant risks for the patient. Non-relevant essential requirements do not have to be
considered. As an example, manufacturers of arm braces made of stretch fabric would have to consider
the essential requirements related to “compatibility between the materials used and biological tissues,”
in other words, the fabric’s potential to cause skin allergies. A non-relevant requirement for arm braces
would be “protection against radiation.” Choice of packaging is an essential requirement for prepackaged
devices, as damage resulting from mishandling could have an adverse impact on the device making it
harmful for the patient upon use. These are just examples, bearing in mind that there are many other
elements to verify and that the manufacturer should carefully review the complete list of essential
requirements.
Use of EU-Wide Harmonized Standards
The task of complying with essential requirements can be simplified by voluntarily using EU (EN)
harmonized standards. The risk assessment management standard which facilitates the initial checking
of the relevant essential requirements is ISO/EN 14971. Manufacturers may also establish their own
checklists for risk assessment of medical devices.
U.S. Commercial Service Healthcare Technologies Resource Guide | 2012–2013
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