Navigating the legal framework for placing Medical Devices (MD) and In Vitro Diagnostic medical devices (IVDs) on the EU market can seem complicated at first, but with careful planning, a successful transition to the new European regulatory landscape is possible.
Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
European Regulatory Framework
The European regulatory framework ensures the safety and efficacy of medical devices and facilitates patients’ access to devices in the European market.
Medical devices within the EU are currently regulated by three Directives:
- Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
- Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
- Directive 98/79/EC of the European Parliament and of the Council on in vitro Diagnostic Medical Devices (IVDMD)
To keep up with advances in science and technology, the three (3) existing Directives are being replaced by two (2) new Regulations that will provide a robust EU legislative framework to ensure better protection of public health and patient safety.
On 25 May 2017 the two new Regulations on medical devices (EU 2017/745) and in vitro diagnostic medical devices (2017/746) entered into full force, and these Regulations will progressively replace the existing directives after a transition period.
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
COVID-19 Medical Devices and (MDs and IVDs)
COVID-19 related medical devices are regulated by the Medical Devices Directive 93/42/EEC (MDD). They can also be placed on the market under the Medical Devices Regulation (MDR). COVID-19 related tests are in vitro diagnostic medical devices and as such regulated by the Directive on in vitro diagnostic medical devices 98/79/EC (IVDD). They can also be placed on the market under the In vitro diagnostic medical devices Regulation (IVDR).
In order to lawfully place on the EU market medical devices and in vitro diagnostic medical devices under the scope of the above mentioned Directives or Regulations, these products must be CE-marked after performing a conformity assessment to confirm that they comply with the relevant legal requirements of the applicable EU legislation.
- Medical face masks or surgical face masks are products falling within the scope of the Directive 93/42/EEC (MDD). It is important to note that some products used in the COVID-19 context, such as protective face masks, are considered personal protective equipment (PPE) and fall under the scope of a different EU Regulation, the EU 2016/425 (PPER). The European Commission has issued a guidance document providing an extensive background explaining the differences.
- COVID-19 diagnostic devices that are designed for professional use, the manufacturer may affix the CE-mark to the product after having ensured the compliance of the device with the Directive and drawn up a declaration of conformity.
- COVID-19 diagnostic devices that are designed for use by lay persons (self-tests), the manufacturer must also apply to a third party body called a notified body who will do additional verification and issue a certificate.
The European Commission provides a list of essential COVID-19 Medical Devices (MDs) and in-vitro diagnostics and (IVDs).
More information on the regulatory framework, together with a number of guidance documents, may be found on the Commission’s dedicated medical devices website.
If you need help to navigate the European regulatory landscape, we are here to provide guidance and help. We have expertise that includes European medical device legislation, Competent Authority supervision, and CE Marking requirements.
Subject Matter Expert
Maria Nyåkern, Ph.D. Founder & Executive Director LinkedIn