Standards and regulations in Europe
Classes on Standards and Regulations on Medical Devices held during the UBORA Design School 2018.
How to place a medical device on the EU market
In order to place a medical device on the EU market, specific European Directives have to be met. The regulatory processes of medical devices are based on the Medical Device Directive (MDD), which consists of three core directives for safety regulations and marketing of medical devices: the Active Implantable Medical Device Directive (AIMDD 90/385/EEC), the Medical Device Directive (MDD 93/42/EEC) and the In Vitro Diagnostic Medical Device Directive (IVDMDD 98/79/EC).
The new European Regulation was recently published: this new Regulation (EU 2017/745) will substitute the current Directives after a 3 to 5 year transition period, ending in May 2020 for Medical Devices and May 2022 for In Vitro Medical Devices.
As proof of compliance to the strict safety requirements of the Directives, manufacturers have to apply a CE mark on their medical devices.
The CE mark can be seen as a declaration of the manufacturer that the product is compliant to the relevant legislations including those related to safety. The CE marking consists of several processes that start from the manufacturer’s choice of the conformity assessment route, which itself depends on the classification of the medical device. It also addresses the evaluation of intrinsic risk and expected benefit. In fact, the classification of a medical device is strongly dependent on its intended use defined by the manufacturer: according to the intended use, length of time used, interaction with the human body and other technical characteristics, the device is considered more or less risky for the patient and therefore classified.
By applying the classification rules of Annex IX of the MDD 93/42/EEC all medical devices are individually placed in one of four classes (Class I, IIa, IIb and III, with Class III as the highest risk class). In cases where a medical device or its features can be classified according to several rules, the highest possible class must be applied. While the 4-level classification structure still holds, the new Regulation is even stricter as several new devices are now placed in the highest class (Class III) with respect to their old I, IIa or IIb positions.
Regardless of the class of the device, all medical devices must be compliant to the Essential Requirements of the directives, intended to enhance patient and user safety and improve device traceability throughout its useful life: some differences between current MDD and future Regulation also apply to the Essential Requirements in as much as a more precise definition has been applied. The core requirement on risk-benefit balance is unaltered but there are new detailed requests regarding validation, clinical proof of benefit and design for the intended user.
Currently MDDs in Europe are enforced by Notified Bodies (NBs), which are independent commercial organizations that provide auditing services for medical devices. NBs have the ability to issue the CE Mark, the official marking required for certain medical devices. There are multiple active NBs in Europe, and companies are free to choose the notified body amongst those designated to cover the particular class of device under review. After approval, post-market surveillance functions must be provided to the NB. This approach is maintained by the new Regulation, although stricter rules for NBs may lead to a reduction in their numbers in the near future. For all classes, excluding Class I non-sterile devices without a measuring function, the manufacturer has to give proof to a NB that their product fulfils these requirements, e.g. by applying relevant standards. A list of harmonized standards is provided by the European Commission and regularly updated. The new Regulation gives power to the Commission to harmonise standards from international organizations and also to issue Common Specifications where no standards are available. If applicable, the manufacturer then submits the entire product documentation to a NB for certification. In case of a successful certification procedure, some countries also require that the manufacturer or authorised representative registers the device with the local National Regulatory Authority (NRA), a competent public agency that can enforce legislation.