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27 March 2019
Asthma , COPD, Allergy, Other Diseases
- Medicines

The European Medicines Agency (EMA) has published a first set of guidelines to help prepare for obligations coming from the new EU legislation on medical devices. The guidelines, formatted as a questions and answers (Q&A) document, focus on article 117 of the medical devices regulation.

The article requires those medicines that are to be used with an integral medical device to include the results of the device’s assessment of conformity by a notified body in order to be marketed within the European Union.

This novelty is of special importance for the safety of people living with allergies and airways diseases, as many of the treatments prescribed need a medical device to be administered (such as inhalers or adrenaline auto-injectors).

Background: New EU legislation coming into force by 2022 the latest

In 2017, the EU placed novel roles and responsibilities to EMA and national competent authorities on medical devices. By 2022 at the latest, the two new regulations, EU 2017/745 & EU 2017/746, will replace the existing medical device Directives, allowing for a transition period for manufacturers.

Medical Devices and medicinal products

The European Medicines Agency distinguishes medicinal devices and medicinal products. While a medical device refers to products or equipment intended for medical use, medicinal products are substances intended (amongst others) to treat, prevent or diagnose a disease.

As there may be combination products (combining a medical device and a medicinal product, as for example pre-filled inhalers) there are also borderline products that cannot be clearly defined as medicinal products.

Further updates on EMA guidelines in the future

The future updates will address, amongst others, substances that are systematically absorbed, borderline products, and in-vitro diagnostic test, used to determine patients' eligibility for a specific medical treatment.

The guidelines can be found at EMA website.