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Home > Blog > Medical Devices

New EU Medical Devices Regulation

Since 2012 the European Union (EU) has been working on the improvement and modernizing of the EU rules on medical devices and in vitro diagnostic medical devices, 93/42/EEC and 98/79/EC, respectively.

The European Council has now issued the consolidated texts of the new Regulations and their corresponding annexes.

The following are some of the major changes that will affect Medical Devices Industry from the entry into force of this new regulation.


Currently it is not always possible to trace medical devices in the market back to the supplier. In order to ensure the traceability of medical devices, the new regulation focuses on the control of products using unique device identification UDI, consisting on a numeric or alpha numeric code unique for each device. With the UDI and a new version of Eudamed, the European database for medical devices, it is intended not only to obtain greater traceability of devices, but also of all economic agents (manufacturers, authorised representatives, importers and distributors), who must register and register the products they manufacture and/or market within this database. Eudamed is also intended to manage, simultaneously in all Member States, the vigilance of the devices, the clinical trials – which will have a unique code for the whole Union – and the post-marketing studies, etc.


Another important point of this new regulation is to the safety of the devices. Patients and healthcare professionals not always have access to the essential information of the clinical evidence of products. Therefore, the new Regulation sets more stringent directives to regulate the post-marketing vigilance through each and every economic agent that shall have available within their organisation, at least one person responsible for regulatory compliance activities who possesses expert knowledge in the field of medical devices. with university degree, or equivalent education recognized by the Member States, in medicine, pharmacy, engineering or another relevant discipline of sciences, and professional experience in regulatory affairs, quality management systems relating to devices and quality management systems.

Furthermore, importers and distributors will also be responsible for checking all the device documentation and for maintaining the conservation and storage conditions specified by manufacturers until the product is placed on the market.

Manufacturers must update during the entire product life cycle, not only the technical documentation, but also the clinical post-marketing vigilance with clinical data. Medical Devices with the highest risk – Class III devices and implantable -, should have a yearly update of the report of clinical post-marketing follow-up and, if applicable, the summary of safety and clinical performance.


EU countries have interpreted and applied the directives in different ways so far, which has led to inequality among users of different countries and, therefore the existence of barriers over the European market.

Regarding the above, there will be changes related to the classification of products that are still being grouped into four groups depending on the risk: Class I, IIa, IIb and III.

All the rules of the medical device directive are maintained, being some of them slightly modified, and four new rules have been added. Products containing or consisting of a nanomaterial are included and will be classified as Class III devices by rule 19. Devices that are composed of substances or combinations of substances that are intended to be introduced into the human body via a body orifice, or applied on skin and that are absorbed by or locally dispersed in the human body are included in Rule 21. These products may move from being currently classified as Class I to be classified as Class IIa or IIb, and even Class III, with all this reclassification involves.

Rule 22 includes all invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are in class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product and those are intended to treat life threatening conditions. Rule 23 classifies active therapeutic devices with an integrated or incorporated diagnostic function, such as closed loop systems or automated external defibrillators. in the group of higher risk: Class III devices.

Notified Bodies

A stricter regulation of the Notified Bodies by the Competent Authorities has been proposed, in order to ensure a much more efficient assessment before placing a device on the market.

A whole chapter of the new Regulation is devoted to Notified Bodies, which would have to be assessed if newly established, or reassessed not only by the Competent Authority of the country in which they are located, but also by a joint assessment team made up of experts from the list of experts appointed by the Member both, led by the national authorities shall conduct an on-site assessment of the Notified Body in question. In the light of this scenario, it is expected that only some Notified Bodies will be able to qualify high-risk devices according to the requirements of this new Regulation, and that during the adaptation period, the Notified Bodies would only issue certificates in the short term – until the end of the transition period in 2019- and not for 5 years as it has been done until now, so this for sure will increase the workload for the certification and recertification of all devices.

Economic Agents

Clearer rights and responsibilities are established for all the involved agents (manufacturers, authorised representatives, importers and distributors).

Implementation and transition period

This new Regulation is expected to be published at the beginning of 2016, and will be adopted three years after its implementation – in 2019 -.

If you require specific support on Medical Devices and how the new regulation will affect your portfolio, you might contact us in the following address: medicaldevices@azierta.eu


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