The European Commission published on April 3rd a Q&A document on medical, implantable active and in vitro diagnostic medical devices to address the emergency situation the medical devices industry is undergoing on a global scale.
This document, as clarified in its text, is of general nature, not comprehensive and does not serve as legal guidance over Council directives 90/385/EEC, 93/42/EEC and 98/79/EC, rather it is meant to guide on the application of the directives themselves.
The Q&A addresses first the definition of each category of devices (medical implantable active and in vitro diagnostic), with particular focus on the concerned provisions in the applicable directives.
Legal requirements under each directive are examined while drawing a distinction between the different level of risk medical devices may pose to human health.
Standards are also considered, both in the Q&A itself and in its Annex 1 and Annex 2, that respectively list all the EU harmonized standards that medical devices manufacturers may choose to use in order to benefit from a presumption of conformity to requirements and the standards recognized by the IMDRF (International Medical Device Regulators Forum).
The document clarifies that the Covid-19 sanitary emergency can be considered as a justified circumstance for the purpose of activating a derogation clause from the directives, that would allow manufacturers to place devices on the market within the territory of the EU Member States for which the conformity assessment procedures may not be perfectly aligned with the requirements.
The grounds for granting such derogations have to be evaluated at national level from the Member State’s competent authorities concerned, that will have to take in consideration the following elements:
1. the degree of criticality of the use of the device for the protection of health;
2. availability of suitable substitutes;
3. documentation of compliance with a harmonised standard or other specific technical solutions ensuring fulfilment of the applicable essential requirements laid down in the relevant Directive;
4. review of reports of tests performed by competent bodies;
5. indications from vigilance and/or market surveillance.
Nevertheless, in spite of any derogation eventually granted, registration obligations of devices and the obligation to appoint a European Authorized Representative for extra-EU manufacturers still stands.
Off label use of medical devices is finally addressed. When off label use of any medical device is deemed strictly necessary, a thorough assessment should be carried out in light of any possible risk posed to the patient’s health. While carrying out this assessment, the following factors should be taken into consideration:
- a documented risk assessment on the use of the device
- consideration of ethical and legal implications
- implementation of suitable precautions to minimise the risk
- reviewing the risk assessment at suitable periods
- obtaining approval from the national competent authorities when required.
Francesca Zuccarello Cimino
If you wish to know more about EU regulation on medical devices and on how to ensure compliance for your devices to safely ship them to the EU to help in the fight against Covid-19, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experiencewith EU legislation, will gladly answer any question you may have and assist you with your products’ compliance.