The Council of the European Union (EU) and representatives of the European Parliament have agreed on two long-awaited draft regulations on medical devices and in vitro diagnostics (IVDs). The text documents were not made available, but the Council says the drafts were deliberated upon to make sure that medical devices and IVDs in Europe are safe while allowing patients to benefit from innovative health care solutions in a timely manner.
“This agreement matters to all citizens: sooner or later all of us enter into contact with medical devices to diagnose, prevent, treat or alleviate diseases. The deal reached will improve patients’ health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25,000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons”, said Edith Schippers, minister of health of the Netherlands and president of the Council, in a press release.
The drafts include measures to strengthen rules on marketing devices and to tighten post-market surveillance. Also, it calls for tighter regulation by national authorities of notified bodies — entities responsible for assessing medical devices against preset standards. Under the new rules, notified bodies will be required to have ready qualified staff but also gain the right to carry out unannounced factory inspections.
According to the release, the draft regulations establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance, and safety of devices placed on the market, as well as for the liability and registering complaints on devices. Patient protection in clinical trials will also be strengthened under the new rules.
High-risk devices, such as implants, that are to be placed on the EU market may undergo an “additional check by experts,” which could be “experts panels and laboratories” assisting notified bodies, authorities, and manufacturers. The draft also explicitly includes certain products without a medical purpose but with similar device characteristics — such as fillers and colored contact lenses for cosmetic purposes — subject to regulation.
In order to improve transparency and surveillance, a central database housing information on economic operators, notified bodies, market surveillance, vigilance, clinical investigations, and certificates will be created and made accessible to the public. Devices will have unique identification numbers (which could be similar to the U.S. FDA’s unique device identifier) for tracking purposes throughout the supply chain all the way to the end-user or patient, who will be given key information on the product, including precautions.
According to RAPS, under the current system implemented in the EU, it is not always possible to establish what companies produce devices marketed there, and what clinical evidence was used to determine a product’s safety. Existing electronic registration tools used by EU member states are thought to be incompatible, making device surveillance across borders challenging.
RAPS adds that the new rules include a proposal to create a Medical Device Coordination Group composed of national representatives that will double check assessments of high-risk devices carried out by notified bodies before the devices are placed on the market.
According to the EU medtech legal and regulatory blog Medical Devices Legal, the agreement forged in the trilogue negotiations led by the Dutch presidency of the Council comes almost four years after the initial proposals were first tackled by the body. The proposed new rules will have to be formally approved by the Council and Parliament (Council’s Permanent Representatives Committee and of the Parliament’s Committee on Environment, Public Health and Food Safety , or ENVI), but the blog author opines that this could be mere formality.
If approved, the new rules take effect three years after publication for medical devices and five years after publication for in vitro diagnostics.
MedTech Europe, the alliance of European medtech industry associations, welcomed the release of long-awaited legislation on modern medical device and IVD technologies after “a long process.”
In a statement, Serge Bernasconi, CEO of MedTech Europe, writes, “As said before, the medical industry recognises the importance of these updated regulations. The implementation will require substantial resources from all stakeholders, including industry. It is thus essential to keep the overarching goals of patient safety and innovation in mind during the translation into implementable rules.”
Image credit: "European Commission flags" by Sébastien Bertrand. Licensed under CC BY 2.0 via Wikimedia Commons.