The Council of the European Union has completed the final versions of its long-awaited Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR), which update the regulatory framework for the marketing of medical devices and in vitro diagnostics in Europe, the world’s second-largest device market.
European lawmakers started the process of overhauling the underlying EU legislation in 2012, and they released draft versions of the text documents in May 2016 after delays and deliberations. The drafts include, among several measures, new rules to tighten regulation by national authorities of notified bodies, stricter post-market surveillance to monitor faulty products, as well as increased patient protection during clinical trials, and added data requirements for study sponsors. The final texts approved by the Council retain much of the same information, except some verbiage.
According to RAPS, an EU official explains that, "The content of the two regulations on medical devices and in vitro diagnostic medical devices is still the same as in the agreement reached between the Council of the EU and the European Parliament in May 2016 which has been approved by the Council on 20 September 2016...The difference between these 'old' documents and the 'new' documents is that the new documents have undergone a legal-linguistic review to make sure that the texts are coherent and equivalent in all 24 official EU languages. So in other words: the wording might have changed, but apart from corrections of some obvious mistakes and addition of necessary clarifications the new EU rules remain unchanged."
The Council of the European Union is scheduled to vote to adopt the MDR and the IVDR on March 7, 2017. The European Parliament will then vote to enact the legislation on March 20, 2017. After a three-year transition period, the new MDR regulations will take full effect in 2020. IVDR regulations will have a longer transition period of five years, and will be fully implemented in 2022.
In a statement, the Council writes, "The new Regulations aim at modernising the existing legislative framework for the marketing of medical devices and to overcome legal gaps, thereby supporting innovation and the competitiveness of the medical device industry. They should further strengthen patient safety, notably through the introduction of more stringent procedures for conformity assessment and for post market surveillance and through requirements on manufacturers to generate clinical data providing evidence on safety, performance and any undesirable side-effects. They should also allow rapid and cost-efficient market access for innovative medical devices."
In the interim between likely legislative approval in March and formal implementation years away, device and IVD manufacturers and companies based or operating in Europe are enjoined to prepare time and resources to adapt to stricter, more complex requirements.
These measures include incorporating unique device identifiers (UDI) on all medical device labels, as stipulated by new MDR regulations. These 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.
The Council states that, "The provisions regarding registration of devices and economic operators, in particular those governing the Unique Device Identification system have been complemented and clarified."
EU manufacturers would be wise to learn from the experience of United States companies in implementing their UDI programs, according to Steve Cottrell of Maetrics, and Madris Tomes of Device Events.
New rules require that UDI and other pertinent medical data will be accessed by an even wider audience of market participants, through a revamped European Database for Medical Devices (Eudamed), "to facilitate more transparency in terms of where in Europe devices have been distributed and which parties are responsible for those products," writes Ronald Boumans, senior global regulatory consultant at Emergo.
The two regulations also include transitional provisions permitting CE Certificates of Conformity issued by notified bodies in accordance with the current Directives, and prior to the date of the entry into force of the MDR and IVDR, to remain valid until the end of the period indicated on the certificates, reports Lexology.