CommentaryFrom OT Europe

New EU medical device regulations could impact future availability of orthopaedic implants

On April 5, 2017, the European Parliament published its new medical devices regulations and in vitro diagnostic medical devices regulations, which are to be implemented after a transition period of up to 5 years.

We as orthopaedic and trauma surgeons rely on implantable medical devices in our daily practice to save lives, ease pain and restore mobility. The most significant examples are our use of fracture fixation devices and joint replacement prostheses.

Per Kjaersgaard-Andersen, MD
Per Kjaersgaard-Andersen

As safe and well-documented treatment must be of the highest priority when our patients need surgery, new medical device regulations (MDRs) are welcome in light of the current non-transparent way products receive a license to be sold on the European market and especially in light of the use of inferior products with negative outcome for our patients, such as Boneloc cement and some metal-on-metal total hip replacement bearings. However, it is important that the implementation of the new MDR does not jeopardize the availability of high-quality medical devices that are known to enable the safe treatment of patients and avoid compromised outcomes.

Device introduction, supply

A robust regulation that ensures a supply of safe devices and allows monitoring of the introduction and use of devices is essential. Orthopaedic and trauma surgeons are proactive in initiating independent oversight of device performance, such as by using joint replacement registries. It is a natural process for orthopaedic and trauma subspecialties to evaluate and make conclusions regarding the outcome of implants currently on the market. In Denmark, national registries report on outcomes of trauma surgery and joint replacement. Other nations, like United Kingdom and The Netherlands, have introduced independent panels of orthopaedic and trauma surgeons to regularly evaluate the outcome of implants delivered to the market in their two areas of the world. These results are published on official websites and are widely used to secure the use of proven and safe implants.

However, one may be somewhat concerned with the outcome of the current process. Within a few years, the new MDR and in vitro diagnostic medical devices regulations (IVDR) systems will be in place. During that time, new notified bodies need to be designated, established and educated to handle the documentation of new implants, implants already on the market and any devices or instruments used when implanting an approved device. To date, we do not have detailed information about the infrastructure that needs to be established to allow these new regulations to be implemented. However, this also requires expert panels and reference laboratories be established, agreement on common specifications, as well as publication of the standards and guidelines, all of which would help provide uniformity in the interpretation and application of the regulations.

Device availability in jeopardy

Therefore, one may speculate that if there is not full achievement of the aims and objectives of this legislation by the end of the transition period, which is rapidly approaching, not only will the introduction of improved devices be impacted, but the necessary review of all devices currently in use may not be completed. This could result in implants and devices currently in widespread use not being available or possibly withdrawn from the market.

For orthopaedic and trauma surgeons in Europe, an interesting aspect to the outcome of the new MDR and IVDR will be how the industry reacts. As the new process will likely impose extra economical costs upon the companies that have their products proven and analyzed by the notified bodies and expert panels, one may be concerned that the less expensive products already on the market will not be selected to go through the new MDR, thus indirectly reducing the number of available products on the market and increasing the price of those that remain available.

EFORT and its European Affairs Committee is ready to assist the European Commission in all aspects of the new MDR and IVDR process with experts and reference laboratories. It stands ready to discuss how documentation that has already been collected may assist with judging implants already on the market, so that in 2024, we will not face a situation in which proven and well-documented implants are not available because a delay occurred with the new MDR validation process.

Disclosure: Kjaersgaard-Andersen reports no relevant financial disclosures.

On April 5, 2017, the European Parliament published its new medical devices regulations and in vitro diagnostic medical devices regulations, which are to be implemented after a transition period of up to 5 years.

We as orthopaedic and trauma surgeons rely on implantable medical devices in our daily practice to save lives, ease pain and restore mobility. The most significant examples are our use of fracture fixation devices and joint replacement prostheses.

Per Kjaersgaard-Andersen, MD
Per Kjaersgaard-Andersen

As safe and well-documented treatment must be of the highest priority when our patients need surgery, new medical device regulations (MDRs) are welcome in light of the current non-transparent way products receive a license to be sold on the European market and especially in light of the use of inferior products with negative outcome for our patients, such as Boneloc cement and some metal-on-metal total hip replacement bearings. However, it is important that the implementation of the new MDR does not jeopardize the availability of high-quality medical devices that are known to enable the safe treatment of patients and avoid compromised outcomes.

Device introduction, supply

A robust regulation that ensures a supply of safe devices and allows monitoring of the introduction and use of devices is essential. Orthopaedic and trauma surgeons are proactive in initiating independent oversight of device performance, such as by using joint replacement registries. It is a natural process for orthopaedic and trauma subspecialties to evaluate and make conclusions regarding the outcome of implants currently on the market. In Denmark, national registries report on outcomes of trauma surgery and joint replacement. Other nations, like United Kingdom and The Netherlands, have introduced independent panels of orthopaedic and trauma surgeons to regularly evaluate the outcome of implants delivered to the market in their two areas of the world. These results are published on official websites and are widely used to secure the use of proven and safe implants.

However, one may be somewhat concerned with the outcome of the current process. Within a few years, the new MDR and in vitro diagnostic medical devices regulations (IVDR) systems will be in place. During that time, new notified bodies need to be designated, established and educated to handle the documentation of new implants, implants already on the market and any devices or instruments used when implanting an approved device. To date, we do not have detailed information about the infrastructure that needs to be established to allow these new regulations to be implemented. However, this also requires expert panels and reference laboratories be established, agreement on common specifications, as well as publication of the standards and guidelines, all of which would help provide uniformity in the interpretation and application of the regulations.

PAGE BREAK

Device availability in jeopardy

Therefore, one may speculate that if there is not full achievement of the aims and objectives of this legislation by the end of the transition period, which is rapidly approaching, not only will the introduction of improved devices be impacted, but the necessary review of all devices currently in use may not be completed. This could result in implants and devices currently in widespread use not being available or possibly withdrawn from the market.

For orthopaedic and trauma surgeons in Europe, an interesting aspect to the outcome of the new MDR and IVDR will be how the industry reacts. As the new process will likely impose extra economical costs upon the companies that have their products proven and analyzed by the notified bodies and expert panels, one may be concerned that the less expensive products already on the market will not be selected to go through the new MDR, thus indirectly reducing the number of available products on the market and increasing the price of those that remain available.

EFORT and its European Affairs Committee is ready to assist the European Commission in all aspects of the new MDR and IVDR process with experts and reference laboratories. It stands ready to discuss how documentation that has already been collected may assist with judging implants already on the market, so that in 2024, we will not face a situation in which proven and well-documented implants are not available because a delay occurred with the new MDR validation process.

Disclosure: Kjaersgaard-Andersen reports no relevant financial disclosures.