The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic.
According to the European Commission, the Medical Devices Regulation (MDR) seeks to ensure a high level of public health and patient safety taking into account scientific progress.
The regulation entered into force in May 2017, replacing the Medical Devices Directive. This transition period helped to avoid market disruptions and some transitional provisions are in place until 2025.
It brings forward a set of new standards and requirements which products must comply with.
In a statement on its website, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) welcomed the regulation, but raised concerns about the “plethora” of EU legislation that relates to medical devices.
COCIR said that discussions about cybersecurity requirements under the Radio Equipment Directive and the future Artificial Intelligence Act highlighted how the complexity of regulations “requires constant vigilance to avoid duplications and unnecessary burden on manufacturers.”
WHY IT MATTERS
There are more than 500,000 types of medical devices on the market and most people will need to use a medical device at some point in their lives.
The EU says the new regulation is intended to pave the way for a “more patient-friendly environment, where transparency and patients’ information and choice are a priority, and where patients can benefit from innovative, high-performing devices and new therapies.”
THE LARGER CONTEXT
The MDR is complemented by the new Regulation on in vitro diagnostic medical devices with a date of application on 26 May 2022.
ON THE RECORD
COCIR said in a statement on its website: “Much remains to be done. Implementation efforts will not stop at the date of application. Continued investment in resources is necessary by regulators, Notified Bodies, and manufacturers to finalise much-needed guidance documents and set-up infrastructure like the European database on medical devices (EUDAMED) or expert panels. COCIR and our members will stay engaged in this process together with EU regulators, also through the Medical Device Coordination Group.”
Irish Medtech Association, senior executive, Dr Áine Fox said: “The Irish medtech sector has invested heavily in changes to business and training staff to progress adherence to the new regulation. However, challenges remain concerning the readiness and capacity of the new system.
“The need for competent authorities and notified bodies to apply the requirements of the regulation in a harmonised way across EU Member States is also critically important. Without consistent implementation of the new rules, roadblocks will limit the sector’s ability to supply certified devices. This is especially true for startups and SMEs which are significant drivers of disruptive innovation in the sector.
“Our members are committed to the success of the new regulatory regime to ensure that life-changing medical devices developed and manufactured in Ireland continue to reach international markets in a timely manner.”