Medical devices can increase life expectancy and quality of life. They are also fundamental for chronic disease patients as they help them manage their symptoms, contributing to patient-centred and disease self-management. Medical devices cover a huge spectrum of products, from home-use items such as sticking plasters, contact lenses and pregnancy tests to dental filling materials, x-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
Medical devices legislation
Rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s, but the existing regulatory framework does not correspond anymore with the current situation in terms of technological and scientific progress. To overcome this situation, the European Commission proposed changes to the legislations on medical devices and in-vitro diagnostic medical devices. If they are adopted by the European Parliament and the Council, they will replace the existing European legal framework that regulates among others inhalers, nebulisers and adrenaline injectors, which are vital for patients with asthma, allergy and COPD.
Inhalers, nebulisers and adrenaline injectors are widely used medical devices for asthma and COPD patients. They are small, handheld devices that deliver a puff of medicine into the airways. Inhalers and nebulisers have the same purpose: to get the drugs into the lungs where you need them. Both deliver the same types of medicine and both are equally effective when used properly. In case of anaphylaxis, the lives of allergic patients having a record of severe allergic reactions can be saved thanks to a medical device that injects epinephrine into their bodies.
Given the importance of medical devices for asthma, allergy and COPD patients, we at EFA advocate for:
- A stricter regulation with increased patient involvement of medical devices that ensures patient safety above market conditions;
- m-Health solutions to be considered in certain cases as medical devices;
- Systematic quality check and control of medical devices components with greater transparency and information provided to the public.
EFA documents and activities in medical devices
- Letter to the Council of the European Union on MDR– January 2014
- Letter to the EP plenary on MDR– October 2013
- Letter to ENVI on MDR– September 2013
- Letter on F-gases to the ENVI – June 2013
- Briefing on the Commission’s proposal for the new medical devices regulation– January 2013