The following information is a summary of the requirements of the Directive. It is not an area in which we currently offer advice but you may find some useful information and links here.
This page describes the Medical Devices Directive which is due to be replaced by the Medical Devices Regulation in 2020. A new page on the Regulation is in preparation and will be linked from here when it is ready to be published.
In response to the Coronavirus crisis, the European Commission have introduced a proposal to delay implementation of the Medical Devices Regulation by a year. The information given on this page therefore remains valid for any medical devices produced to meet the current crisis.
The main differences between the Directive and the Regulation are as follows:
- Wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified as regards genetic tests;
- Stronger supervision of independent conformity assessment bodies (so called notified bodies') by national authorities;
- More powers for notified bodies vis-à-vis the manufacturers, to ensure thorough testing and regular checks, including unannounced factory inspections at manufacturing sites;
- Clearer rights and responsibilities for manufacturers, authorised representatives, importers and distributors, including in the case of diagnostic services and internet sales;
- Extended database on medical devices (Eudamed), providing comprehensive and public information on products available on the EU market;
- Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns (e.g. recalls);
- Reinforced rules for clinical investigations on devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices, including in vitro diagnostic medical devices.
- Adaptation of the general health and safety requirements, including labelling provisions, to the technological and scientific progress.
- Introduction of classification rules that divide the broad range of in vitro diagnostic medical devices into four different risk classes as it already exists for other medical devices.
- Creation of a Medical Device Coordination Group composed of members representing national competent authorities in the field of medical devices to ensure better coordination between Member States, with the Commission providing the necessary scientific, technical and logistic support.
The basic structure and requirements of the Regulation remain the same as for the Directive, with medical devices being grouped into four risk categories based on a set of classification rules, and the level of external assessment required for CE marking increasing with the risk.
The Medical Devices Directive (93/42/EEC), along with two associated directives (the Active Implantable Medical Devices Directive and the In Vitro Diagnostic Devices Directive) cover all medical equipment. This directive includes equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. The Directive excludes any products which come within the scope of one of the other two medical device directives.
The Medical Devices Directive has a very wide scope and it is important to realize that the intended purpose and the way a product is marketed can cause them to be covered or excluded. The Directive defines and applies different administrative requirements to four classifications of medical device. These classifications are based on the risk a device presents to the public, as defined through a series of classification rules.
The Directive came fully into force in June 1998 and is enforced in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).