With over 5,00,000 types of Medical Devices (MDs) and in-vitro diagnostics (IVDs) existing, the European MD and IVD market stands as a major economic player. On the other side, recent scandals pertaining to certain classes of medical devices exposed the frailties of medical device regulations in the region. With the growing concerns about the weaknesses in the current system, the European Union (EU) was in plans to implement tougher rules governing the safety and monitoring of medical devices. In a recent announcement, it is learned that the European Parliament has adopted the proposed regulations unanimously without any amendments.

How is it evolved?

Let us consider recent scandals that triggered stricter regulations. In a global scandal over French-made breast implants, investigations revealed how hundreds of thousands of women around the world had been implanted with substandard silicone products made by defunct French company Poly Implant Prothese (PIP), which safety regulators had failed to stop for more than a decade. Another scandal that involved “metal-on-metal” hip replacements rocked the medical devices market in the European Union. The replacements which were supposed to offer easy mobility for ten to fifteen years failed much sooner than that and left thousands of patients in crippling pain. It is also said that artificial hips have eventually caused non-cancerous tumours, allergic reactions and loss of muscle mass and bone strength. These two scandals primarily prompted calls for Europe to toughen controls on medical devices.

Moreover, even when these devices are getting more innovative and sophistically designed by the day, the existing regulations date back to the 1900s and have failed to keep at par with increasing scientific and technological development in the healthcare sector. Also, keeping in mind how there will be twice as many Europeans aged 65 and above by 2060(are we looking that far), and how vital medical devices and IVDs are for public health and medical care, the European Commission finally proposed a revamped set of regulations in 2012. The proposal has cleared its final legislative hurdle after the European Parliament has adopted the proposed regulations without amendment.

What does the proposed regulations include?

Based on the multi-year negotiations between EC, EP and Council the proposed regulations may come include:

• stricter premarket review of high-risk devices
• strengthened designation criteria for notified bodies
• improved traceability
• a risk-based classification system for IVDs

The new rules are expected to tighten the controls and ensure medical devices to be safe and effective apart from expected to better reflect scientific and technological progress in the medical device industry. In addition, the anticipated regulations may introduce simplified one-time product registration at the EU level, better member state coordination in market surveillance, unique device identifier (UDI) requirements, and setting up of a comprehensive EU database on medical devices by 2020.

When will they be implemented?

The Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) are set to be formally published in the Official Journal of the European Union in May. Once they are officially published, the new regulations will be fully applicable after a transition period of:

• three years for medical devices
• five years in case of in-vitro diagnostic medical devices

With all done, the new regulations may come into existence any time soon. How prepared are you with new and renewal dossiers, will be looked upon in last minute? You might need help in dealing with the complexities of the new MD and IVD regulations. Get in touch with a Regulatory industry expert to avoid last minute hurdles and seek clarity and a pragmatic approach to deal with the situation.