New guidance issued by the European Medicines Agency on medical devices aims to streamline procedures, but integrating technologies into healthcare systems remains challenging, warns the Polish industry.

A new version of the guidelines for medical devices and in vitro diagnostics has been published by the European Medicines Agency (EMA). It is now available to applicants, marketing authorization holders, and notified bodies in the field of medical devices.

The Polish Chamber of Commerce of Medical Devices POLMED said: “The new guidelines will enhance the understanding and implementation of the relatively new regulations on medical devices and in vitro diagnostic medical devices.”

“Both the EMA guidelines and the previously issued guidelines by Medical Device Coordination Group (MDCG) contribute to increased harmonisation of regulations across all EU member states,” POLMED told Euractiv.

Medical Devices

The medical devices category includes tools, instruments, machines, or implants used in healthcare to diagnose, prevent, monitor, or treat diseases and medical conditions. They range from simple items like bandages and thermometers to complex technologies like pacemakers, MRI machines, and even robots performing intricate surgical operations.

“These medical devices support patient recovery, prevent social exclusion, and help overcome daily life barriers,” Arkadiusz Grądkowski, President of the POLMED Chamber and Board Member of MedTech Europe, told Euractiv.

“In short, they provide the best possible functionality and quality of life, protect privacy, and ensure dignity,” he added.

The medical devices sector is also the second most innovative industry in Europe.

It is generally believed that there are over 2 million different types of medical devices available globally. These devices are categorised into more than 22,000 generic groups, reflecting the vast diversity and specialisation within medical technology.

In Poland, approximately 300,000 medical devices are available. Many of these play a crucial role in accelerating the healing process and enhancing the quality of life for seniors, many of whom suffer from multiple health conditions.

As the population ages, the demand in this area is expected to grow significantly, making access to these devices even more critical.

Polish implementation issues

While medical devices have a wide range of applications, a bottleneck in their use is the implementation within healthcare systems.

The main issue is the lack of clearly defined pathways for integrating medical devices into the public healthcare system.

This process is further complicated by the diversity of medical devices, which vary greatly even within the same product group and are continuously evolving and improving.

Grądkowski believes that for patients to have good access to a broad range of the latest medical technologies, “we need clear, transparent, and predictable legislation.” He points to two key problems that need to be addressed.

Firstly, only a national consultant or public administration can currently apply. A solution could be to allow manufacturers of medical devices to submit applications as well.

These manufacturers possess crucial information about their products, including the results of research and studies. According to Grądkowski, this change would significantly shorten the entire process.

Secondly, the lack of clearly defined timeframes for each stage of the application process means that procedures often wait years before being implemented into general use.

“Considering how rapidly the industry evolves, it’s fair to say that Polish patients receive these technologies when they are no longer innovative,” Grądkowski said. Establishing specific timeframes for each stage of the application review process would ensure that the entire procedure takes no longer than three months.

Inter-ministerial topic

Additionally, there should be regular updates to the list of medical devices available by prescription, both in terms of the products included and the expansion of funding limits. This process should involve organisations representing patients, national consultants, scientific societies, and the industry.

“Currently, there is no legislative procedure in place to enforce such regular updates on decision-makers,” Grądkowski said.

Poland also lacks a dedicated department within the Ministry of Health to focus specifically on medical devices. Therefore, “the implementation of medical devices into the healthcare system should be a topic of inter-ministerial discussions,” said Professor Agnieszka Neumann-Podczaska, Director of the National Institute of Geriatrics, Rheumatology, and Rehabilitation, during the conference on June 10, 2024.

[By Paulina Mozolewska, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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