artikel | 15 nov 2018

Medical Device Regulation: halfway there?

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Halfway through the implementation period of the EU Medical Device Regulation (MDR), important actions are still to be taken by both the EU and other organisations in this field, in particular companies that supply medical devices. The EU has recently published a new rolling plan for the implementing measures, as well as guidance documents.

A new implementing measures rolling plan
The new legislation on medical devices was adopted by the European Parliament and the Council of the European Union in June 2016 and entered into force on 26 May 2017. Together with the MDR, a regulation on in vitro diagnostic medical devices (the IVDR) was also adopted. The regulations, which cover products such as contact lenses and pacemakers, have been developed to gradually replace the current three directives in this area.

The purpose of the regulations is to ensure that medical devices are safe and effective for EU citizens and healthcare professionals who rely on the devices. In addition, the legislation is intended to foster innovation and improve the competitiveness of the medical device sector. The update of the rules and the ‘upgrade’ from directive to regulation will harmonise application of the provisions throughout the EU and presumably eradicate problems of diverging interpretation and the risk of certain incidents, such as what happened with breast implants under the previous legislation. The new legislation will also cover groups of products similar to medical devices but without an intended medical purpose.

The MDR and IVDR, which entered into force at the same time, will apply in parallel with the previous legislation for a period of three (MDR) and five (IVDR) years, respectively. Consequently, for the MDR the regulation is to be applied from 26 May 2020. However, there is an added complication in that different articles of the regulation are to be applied from different times, meaning that some provisions are already applicable while some provisions will be applicable in a few years’ time. The IVDR is scheduled to apply from 26 May 2022.

A new implementing measures rolling plan for both the MDR and IVDR has recently been published by the EU. The rolling plan consists of a list covering essential implementing acts and actions, which must be put in place by the European Commission during the transition period. The list, structured as a schedule, indicates the subject, the legal basis (what part of the regulation it corresponds to) and a description of what act is to be implemented or what action is to be taken. Furthermore, an expected timeline for final adoption or completion is provided, together with the current situation and the next step. The European Commission will revise the document every quarter to provide updated information to stakeholders and competent authorities.

The first part of the plan
The first part of the rolling plan, regarding implementing acts, concerns the reprocessing of single-use medical devices and common specifications for products without a medical purpose. It includes the setting up of expert panels, expert laboratories and EU reference laboratories. The list also covers the designation of issuing entities for the Unique Device Identification (UDI) system, which will allow easier traceability of medical devices, and the EUDAMED database. In addition, the common specifications for in vitro diagnostic Class D, regarding scrutiny of high-risk devices, are stated as an implementing act in the rolling plan.

The second part of the plan
The second part of the rolling plan, which relates to other actions and initiatives that are important to the application of the MDR and IVDR, covers issues such as notified body designation, an EUDAMED implementation plan, along with functional specifications for the database.

The EUDAMED, European Database on Medical Devices, is being introduced as a database for several electronic systems regarding medical devices. Much of the information will be made publicly available. The systems will include registration of operators, such as manufacturers, authorised representatives, importers and distributors. Device identifier data elements and certificates by notified bodies will be included, along with a system on vigilance, market surveillance and clinical investigations. The database is yet not ready and, according to the rolling plan, EUDAMED is set to be published by 25 March 2020. Work is underway to establish and implement functional specifications.

Other aspects of the regulations
In addition to the database, other issues need to be taken into account. For example, the classification of products will be divided into 22 instead of 18 classifications, which means that some products will receive a new classification. Meanwhile, notified bodies are to undergo an assessment. So far, several notified bodies have lost their license or part of their license. The outcome of Brexit is also important in this context, as many of the products currently available requiring a conformity assessment procedure by a notified body have been reviewed and verified by notified bodies in the United Kingdom.

Under the new regulations, manufacturers must have at least one person in their organisation responsible for regulatory compliance who has the requisite expertise in the field of medical devices. People with this competence are already in short supply and high demand, so quality assurance and regulatory affairs are expected to be important future areas of business.

In October this year the European Commission also published five new guidance documents on Unique Device Identification (UDI). The UDI system will assign labels to all products to simplify traceability, and facilitate market surveillance and monitoring. This is also expected to facilitate recall and correction, prevent counterfeiting, reduce the risk of misuse, and improve logistics for manufacturers and the healthcare sector.

The new regulations will expand the scope of medical device legislation, while also making it clearer. New products will be included and more requirements have to be met. This will affect manufacturers, importers, distributors and notified bodies. The EUDAMED database will contain a large amount of information and much of it will be made publicly available. The UDI system will simplify traceability from manufacturers to consumers, stricter requirements on the clinical data will be applied and classifications updated. According to the EU, the new rules set the gold standard for medical device regulation globally.

So, are we halfway there? We are in terms of time. But are the EU and other organisations in this field ready for the MDR? There are still several major actions to be taken with regard to the new implementing measures rolling plan. Only time will tell if everything is in place at the end of the transition period.



Life Sciences

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