In April last year, the European Parliament formed the new EU Medical Devices Regulation (MDR) and in-vitro Diagnostics Regulations (IVDR). However, the implementation took place in May. The new improvised directive of European Union (EU) addressed the loopholes of the then existing regulatory framework for medical devices.
When the original EU legislation on medical devices was operative, there were incidents of fraudulent activities that threatened the safety and overall health. The reason for these sudden changes in regulation was many. For instance, it came into light that the Poly Implant Prothèse (PIP) implants comprise industrial level silicone in breast implants instead of medical ones. As a result of the PIP had to lose CE mark from its silicone implants. After a thorough review, the UK Department of Health found loose ends in the legal system responsible for the incident. Similar other instances compelled the EU to replace the present law with a more vigilant and sustainable one.
Adding to the worry of the EU was the DePuy incident in the year 2010 that created panic and fear among providers and patients. The company DePuy manufactured metal-on-metal hip implants. A worldwide data revealed some harsh facts about those implants. Some incidents related to DePuy’s implants raised questions about its quality. Patients using them had to go for a second hip replacement. Also, data on the leaking of chromium and cobalt from the implants started to spread. This created concern about how these materials can get diffused into the blood and increase cancer risks in patients. As a result, DePuy had to take back the products from the market. People began to question how safe was life amidst such deceitful medical device cases.
Purpose of the new regulation
By bringing in the new set of medical device regulations, the EU parliament ensures the following aspects:
- Increased safety of EU citizens using medical devices that fall under the new directive
- Improved health quality of EU citizens
- The practice of free and fair trade of medical devices throughout the EU territory
- Support for scientific and technological progress without compromising on the quality of care
Changes that took place in the legal framework of medical devices in Europe
Here are the three notable changes that the new regulation offers:
Reclassification and Broadening of Medical Devices Scope
To ensure that a more extensive set of products fall under the regulation, EU broadens the definition of medical devices. A notable change is the inclusion of software under the category of ‘medical devices.’ This was done to keep the legislation in sync with the latest technological changes. Also, the regulations included products that have no intended medical purpose such as contact lenses, lasers for skin treatment, etc. Moreover, some devices that earlier belonged to medium or no risk category made way into high-risk one. All these changes indicate that approval from notified bodies is compulsory when dealing with the specified medical devices in the regulation.
Improved Transparency and Strict Vigilance
Governing bodies doesn’t want to take the risk. That is why with the changes in the regulation EU intends to bring in more transparency into the picture. Now, with the new directive in use, medical device manufacturers in EU need to acquire a unique device identifier (UDI) for every device. Later, this code will make its way into the European database (EUDAMED) through which it becomes easier to track the journey of the medical device through the supply chain.
Moreover, the new legal structure gives a massive boost to the surveillance aspect of the devices. With expanded market reach and enhanced post-market surveillance, EU hopes to improve safety. Moreover, with better incentive plans, the regulatory body wants to encourage business to stay compliant. Now, with a new law in existence, authorities can make unannounced visits to manufacturing units and conduct audits any time.
All are Accountable Now
Earlier, any fault in the medical device, manufacturers were held liable. But with the changes in the regulation, every participant of the supply chain is responsible for anything that goes wrong. It is the liability of all to ensure that product is top-notch and in compliance with the legal guidelines. Even the entities outside the territory of EU are not left out. They will require having authorized representatives within the EU against whom regulatory authority can act in case of any non-compliance issue.