The EU Medical Devices Regulation for greater patient safety

The EU Medical Devices Regulation for more patient safety
Objective: to improve the quality of medical devices
The market for medical devices and the associated requirements have received a lot of attention since 2010 due to a scandal that came to light. The French manufacturer Poly Implant Prothèse (PIP) decided to use an unauthorized industrial silicone for its breast implants for cost reasons, among other things. These implants were sold and used on the market for years. As a result, hundreds of thousands of patients are struggling with the risks of the substandard implants, which can rupture, cause irritation and inflammation, and ultimately require further surgery. In response, the European Commission revised the existing regulations.
Strengthening the quality of medical devices

The implant scandal led to a significant tightening of the requirements for medical devices. On May 25, 2017, the new EU Medical Device Regulation (MDR) came into force together with the new In Vitro Diagnostics Regulation (IVDR). The MDR came into force on May 26, 2021, after a transitional period of four years. For medical device manufacturers, this means, among other things, that higher demands are placed on the technical documentation of the manufacturing processes, on quality management and on the clinical evaluation over the entire product life cycle.
The aim is to improve patient safety by increasing the quality of medical devices without restricting innovation.
However, the MDR regulations not only affect new market entries, but also higher-class medical devices that are already on the market. These must also undergo re-certification according to the MDR. This requires a sufficient number of certification bodies, so-called “notified bodies”, i.e. state-authorized bodies that carry out tests and evaluations. Likewise, there are products that require certification from the “notified body” for the first time due to the MDR, such as reusable surgical instruments or higher-class medical software. The transition period for the re-certification of existing products is to expire in 2024.
Impact of the MDR on care

Although the MDR came into force more than six years ago, the system is still being developed. This also leads to long waiting times for the issuance of MDR certificates. Despite the increasing numbers, the capacities of the “notified bodies” are still too low to cover the increased testing and certification effort. For this reason, the transition period has been extended from May 2024 to the end of 2027 for products with higher risk (such as pacemakers) and to the end of 2028 for products with medium and lower risk (such as syringes or reusable surgical instruments).
Manufacturers are already struggling with the conditions. They have to expect increased requirements, waiting times and, above all, higher costs. This will result in them having to withdraw products or entire product lines from the market. This applies to both existing and niche products. The same also applies to innovative products, meaning that some manufacturers will partially migrate from EU markets.
The consequences of the MDR described above will also affect healthcare facilities such as hospitals. When manufacturers withdraw their products from the market, hospitals are forced to change manufacturers. Supply bottlenecks mean that substitute products have to be used more often. Rare niche products are even more difficult to obtain and innovative products take a long time to come on stream. Above all, this means that staff providing patient care face additional challenges.
Safe use of medical devices

Anyone who uses a medical device on a patient must have the necessary training or knowledge and experience, and must be instructed in how to use it safely.
From practical experience, it is known that these requirements from the Medical Devices Operator Ordinance are often difficult to implement. A low degree of standardization or a frequent change of medical devices, as is currently often the case, further increases the effort required for safe use and demands increased attention from staff.
The following factors can support the safe use of medical devices in hospitals:

Communication:

If there is a change of manufacturer or supply bottlenecks, and thus the use of new medical devices, then this information should be made available at an early stage via internal communication channels. Regular integration into existing meetings and an exchange of information about special features in the use of the products can promote safe handling.

Instruction:

Even if medical devices are used rarely or only for a short time, the user must ensure that they have the necessary basic knowledge of how the medical device works and an understanding of the risks. The user must have an overview of the medical devices currently in use in their area of work. They should request any necessary training as part of their duty to obtain information. The operator must ensure the organizational framework is in place and that all users receive the necessary training.

Safety culture:

Strengthening a safety culture supports the safe use of medical devices. Among other things, a safety culture provides a framework in which it is possible to express uncertainties, identify and analyze safety gaps, and take the appropriate precautions. This concerns training measures, the design of medical devices, and the open exchange of information.

Conclusion

Medical devices play a crucial role in the daily care of patients. With its strict requirements for medical devices, the MDR makes an important contribution to patient safety, so that cases like the implant scandal mentioned at the beginning of this article will hopefully be a thing of the past. In practice, however, the shortcomings of the regulation are also becoming apparent. Long waiting times and rising costs present new challenges for manufacturers and hospitals. The resulting demand from associations such as the German Medical Technology Association (BVMed), to make the implementation of the MDR more practicable, continues to be loud and suggests that further adjustments are likely.
In the already highly stressed system of health care, this means an additional challenge, especially for staff. A changing or incomplete range of medical devices not only requires more instruction, but also increased attention to avoid mistakes in patient treatment. This makes it all the more important to strengthen open communication and a culture of safety to promote patient safety.
Literature
www.bvmed.de/de/recht/eu-medizinprodukte-verordnung-mdr
www.aps-ev.de/wp-content/uploads/2017/04/HE-Einweisung-von-MP.pdf

Medical Device Operator Ordinance - MPBetreibV

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending

Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.)