Medical devices conform a wide range of products used for healthcare, from bandages to implantable devices or radiotherapy machines. They can be products used from diagnosis and prevention, to treatment of diseases. In-vitro medical devices are those which are used for the in-vitro examination, to provide information for diagnostic or monitoring.
In 2017, the regulatory framework from the EU on medical devices has been updated, following a proposal by the Commission from 2012. On the one hand, the Directives on active implantable medical devices and on medical devices have been merged and updated in the new Regulation 2017/745 on medical devices, On the other hand, the Directive on in-vitro diagnostic medical devices has been replaced by the new Regulation 2017/746 on in-vitro diagnostic medical devices.
The Regulations enter into force soon after they are published, but there are transitional periods of application, which refer to when all devices will be required to comply with the new rules. For the Medical Devices Regulation, it will be applicable three years after publication. For In-Vitro MD Regulation, it will be applicable five years after publication. Manufacturers are given those years to adapt.
Context and content
The main objective of the new Regulations is to ensure elevated levels of health and safety protection, following some scandals with medical devices in other areas different than cancer treatment. They also aim at adapting the existing rules to the innovations occurred throughout the last decades, given the age of the previous Directives.
To ensure protection, the Regulations tighten the rules on approval procedures. Unlike pharmaceuticals, medical devices do not follow a strict EU procedure. They undergo a decentralised system of conformity assessment bodies, or notified bodies. The new Regulations have revised this system, putting in place closer scrutiny of devices based on their risk class, requiring for the opinion of expert panels before the notified bodies can issue certificates. There are 52 notified bodies that, upon being certified, oversee the safety of all new products.
At the same time, there are stricter requirements in terms of the expertise required from notified bodies and national competent authorities that supervise them. The Regulations also introduce new measures to assure traceability of devices, through more monitoring and post-market checks. These post-market checks include random inspection of producer’s facilities, implant cards for patients, and many other measures. A more detailed description can be found in this press release from the Parliament.
Under the new rules a new public registry of medical devices will be created, in order to help tracking the devices and their safety across the EU.
Incidence in cancer patients
The new regulations categorize different medical devices in several classes, depending on their characteristics. Then, there are different rules and varying scopes of protection between these classes. Those devices that comprise high risks will be scrutinized more closely. This classification can have implications in other topics of regulations, such as in health technology assessments, which ultimately also affect the needs of cancer patients.
At the same time, there are new stricter rules on DNA tests, prior and after authorisation. These rules include ethical requirements, such as the obligation to inform patients of the consequences of DNA tests.
Way forward
After the overhaul of the Regulations on medical devices, it is time for the European Commission to make sure that the complex and extensive new rules are correctly applied in every Member State. Manufacturers have now three to five years to adapt (see the transitional periods of application explained above). The focus will be now in monitoring the compliance and making sure that both authorities and companies observe the new requirements.