Comment: Medical Devices Face Stronger Regulation

Published on: 1 July 2016


A new era in the regulation of medical devices will improve public understanding of products, help to promote self care and will bring benefits for the market in the long-term.

From heat patches and head lice treatment to eye drops, you will be familiar with the fast growing range of medical devices currently available for self-treatable conditions on shelf in pharmacy. However, for most customers, understanding the difference between an over-the-counter (OTC) medicine and a substance based medical device, which look alike and treat the same condition, may be difficult. Despite such visual similarities the regulations governing these product categories are disparate.

A new regulatory framework for medical devices in Europe is fast approaching. The aim of the revisions is to modernise the current legislation, to make sure medical devices are safe, can be traded across the EU and that new innovative devices reach the market in a timely manner. The new legislation will increase the scrutiny of products before they enter the market and tighten surveillance once they are available, helping to restore public confidence following scandals surrounding medical devices, such as PIP breast implants.

Two new Regulations will replace the current Directives and will cover all medical devices and in vitro diagnostic medical devices, including products sold within pharmacies, from pregnancy tests to contact lenses.

At PAGB, we have a long and distinguished track record as the self-regulatory body ensuring balanced and responsible marketing of branded OTC medicines and food supplements. As we prepare for the new Medical Device Regulations to take effect, we have been working closely with our member companies, the regulator and other self-regulatory bodies to develop specific advertising guidance for substance based medical devices in order to maintain the high standards of promotion across the UK self care industry.

So what will this mean for pharmacies? Although, at first the new legislation will put the industry under scrutiny, the longer term benefit of having a safer, more regulated approach will no doubt encourage a positive sales environment for pharmacies, as customers will become more confident and empowered to look for products for self-treatable conditions.