16 June 2017
Laws Regulating All Types of Medical Devices Published in Official Journal
Two new Regulations laying down rules on the marketing of medical devices have been published in the Official Journal of the European Union. These are Regulation 2017/745 on medical devices (the ‘MD Regulation’) and Regulation 2017/746 on in vitro diagnostic medical devices (the ‘IVMD Regulation’). Manufacturers and distributors of such devices can soon expect more stringent compliance requirements and a whole range of new obligations. While both laws were published in the Official Journal on 5 May 2017, the MD Regulation will apply from 26 May 2020 and the IVMD Regulation will apply from 26 May 2022.
Together the Regulations establish a new updated legal framework for the supply of a wide range of medical devices to EU customers. Everything from bandages, syringes, surgical instruments and thermometers, as well as more complex products such as blood pressure monitors, pacemakers and radio-imaging equipment fall within their scope of application. Moreover, certain products that lack a medical purpose but are considered equivalent in terms of risk are included (e.g., skin fillers and coloured contact lenses), in addition to products used for cleaning, disinfection and sterilisation.
Hong Kong and mainland Chinese manufacturers which export any of these types of goods to the EU market will need to carefully assess how they can comply with the new framework. Cross-border sellers to customers in different Member States will also need to take steps.
As a general overview, the new Regulations strive to improve the safety, reliability and quality of medical devices. This is intended to be achieved by offering a truly harmonised approach to their marketing and by adapting to the technological advancements that have occurred over the past 25 years. A strong emphasis is also placed on resolving the structural weaknesses that undermine the existing approval and surveillance regime for medical devices in the EU.
In practical terms for businesses, this means the introduction of more complex conformity assessment procedures (especially for high-risk devices), more complete rules on market vigilance and new rules on product liability. The possibility for Member States to introduce penalties so as to promote compliance has been introduced. In addition, EU guidelines which were not previously legally binding have been incorporated into the Regulations, thereby reducing flexibility for industry.
Importantly, the new framework maintains the existing classification system for medical devices which divides products into different classes according to risk; class I (low-risk), class IIa and IIb (moderate risk) and class III (high risk). These classes play an important role in determining the rules and level of scrutiny that apply to a particular device.
In fact, economic operators should note that some of the rules for classification have changed, meaning several devices (e.g., medical apps) have had their risk class increased. As a consequence, manufacturers who were able to self-certify their products under the pre-existing regime may now find that registration with a Notifying Body will be required.
A further change to the pre-existing regime is the more prominent role that clinical data and evaluations have been given in the regulatory process. For instance, the possibility to rely on studies done with other types of devices to demonstrate clinical safety or performance has been greatly reduced. For most implantable high risk devices, clinical investigations will be absolutely necessary.
There are also new rules on design and manufacturing contained in Chapter II, Annex I of the Regulations. By way of example, one of the provisions in the MD Regulation provides that for devices containing more than 0.1% in weight of a carcinogenic, mutagenic or toxic substance or a substance with endocrine properties, the manufacturer must be able to justify that substance’s presence.
Regarding market surveillance, manufacturers are required to supply the competent authorities, on a more regular basis, with all information necessary to demonstrate conformity. Once devices are on the market, they will have to collect data about their performance and to share that information with patients who are seeking compensation. Such requirements will likely impact on manufacturers’ technical documentation.
The Regulations also introduce new general obligations for distributors who will have to verify that their products are CE marked and that an EU declaration of conformity has been completed. Products will also have to be accompanied by labels and instructions for use, drawn up in accordance with Chapter III of Annex I of the Regulations. In the case of medical devices, there is a new requirement that there should be an indication on the label that the product is a medical device. This may result in the introduction of a new ‘MD’ symbol for medical devices, similar to the ‘IVD’ symbol which already exists for in vitro medical devices.
There are also new rules on the reporting of complaints and suspected incidents related to the medical device, for distributors and manufacturers. Manufacturers will be required to report a serious incident to the relevant competent authorities within 2, 10 or 15 days, depending on its gravity. Moreover, manufacturers will have to report non-serious incidents to the controlling authority within 15 days, together with an explanation as to why this constitutes a non-serious incident.
Reporting will be carried out through EUDAMED; a new central database to be set up which will integrate several existing electronic systems to bring together information on medical devices and economic operators on the medical devices market. Information on conformity assessments, clinical investigations and market surveillance, among other matters, will be collated.
The new framework also calls for the introduction of a unique device identifier (UDI) requiring medical devices to be labelled with a unique product number, specific to the manufacturer and the device. Information about the device corresponding to the number will then be stored in EUDAMED.
Given the multitude of new requirements, companies should foresee the possibility that significant changes to their internal processes may be required. While both Regulations took effect on 25 May 2017, the new provisions will not apply until 26 May 2020 in the case of medical devices and 26 May 2022 in the case of in vitro medical devices. Any new products placed on the market from those dates will, in general, need to comply with the new rules.