When looking at technical standardisation, it is important to remember that its main purpose is to reduce technical barriers to international trade, to achieve savings through increased efficiency and interoperability, to enhance consumer protection and also to support the regulatory framework for products. However, the role of technical standards has sometimes been perceived as contradictory in the field of medical devices. And for some manufacturers, these standards have sometimes been a deterrent, as they have allowed third parties to objectively assess their medical device and have sometimes reminded them of gaps in their own knowledge. Fortunately, most manufacturers are already well aware of how good an aid technical standards are for them in assessing GSPR compliance. So how to work with standards properly?
Although there is a framework for joint activities at IMDRF, different regulatory frameworks use technical standards differently. The FDA requirements for the US market and the MHRA requirements for the UK market are different from the EU requirements when assessing compliance using technical standards or common specifications. We will only discuss EU regulation, for which the concept of harmonised standards, i.e. standards to which reference has been published in the Official Journal of the EU, is relevant. It is also important to be familiar with the MDCG 2021-5 Guidance on standardisation for medical devices, issued by the Medical Devices Coordination Group. In this document, the MDCG states the requirement for manufacturers to always use the latest edition of standards, as it reflects the latest state of knowledge, in other words the state of the art, even if an older edition of the standard is published in the Official Journal of the EU. It also states that compliance with the latest edition of a standard does not automatically imply compliance with the requirements of the applicable EU legislation. Moreover, the use of standards is voluntary. How to get out of this mess? Simple actually - the manufacturer must provide evidence in the device's technical documentation of how the device meets the requirements of the legislation and document the state of the art. The Notified Body must check that the device meets the requirements of the MDR or IVDR, but even it cannot require a specific standard as mandatory. Manufacturers may therefore be advised to discuss in advance with their notified body how they will review technical documentation regarding state of the art and references to standards.
To be continued.
Author: Aleš Martinovský