CommentaryFrom OT Europe

New EU medical device regulation may impact orthopaedics, traumatology

The European Union Commission has launched a new medical device regulation for devices sold in the European Union that replaces the existing medical device directive. Under the new regulation, devices on the market are classified into one of three levels, with class 3 consisting of high-risk devices that need the strictest regulations.

Per Kjaersgaard-Andersen, MD
Per Kjaersgaard-Andersen

All orthopaedic and traumatology implants are class 3. A 3-year transition period from May 2017 until May 2020 was initiated to implement the new medical device regulation (MDR) system. It means that starting May 26, 2020, new implants introduced to the European market must comply with the new MDR. However, for some implants, the existing medical device directive (MDD) may remain in effect until May 2024, after which the MDR will be in the only device regulation in place.

Improved product safety

What does this mean for surgeons who practice orthopaedics and traumatology? The most visible benefit from the new MDR is that new implants introduced to the European market will have undergone a significant regulation process to improve safety for our patients, followed by strict post-market surveillance. Manufacturers claim this approach surely will result in fewer new products introduced to the market, a slower rate of new implant introduction compared to when other regional regulations are used and increased prices for the new implants.

That being said, innovation will never stop. New initiatives will appear. I am sure the manufacturers of medical devices that are now part of the European market slowly will adapt and maintain their current share of the overall orthopaedic and traumatology market.

On behalf of orthopaedic and traumatology surgeons in Europe and our patients, I welcome what the new MDR system means for products being introduced to the EU market because it will surely increase patient safety by reducing the risk of unexpected adverse events from implants and help avoid patient suffering.

Performance evaluation

However, implementation of the new MDR will affect products on the market now, as well as those that are just being introduced. Through the re-evaluation of implants that are already used in patients, the EU Commission aims to continuously validate all implants based on their performance and to potentially withdraw from the market those implants that fail to perform well in patients in the longer term. I also welcome this strategy for existing orthopaedic devices in the name of patient safety. However, it also concerns me. The new MDR for class 3 implants that are already on the market will require high-level, qualitative, clinical data to prove the safety of the implants. Although the level and amount of data needed for these products have not yet been published by the EU, I foresee a process that significantly increases product cost because it is possible that the manufacturers will need to deliver that data. This may result in the need for manufacturers to reduce the number of implants they sell, which may result in fewer implants that are available. Also, some smaller companies close because their products are no longer profitable for them.

Some implants, such as total hip and knee prostheses, have more “big data” on their performance and survivorship available from high-quality national registries. Therefore, it is my hope the EU Commission, the notified bodies, the upcoming expert panels and EFORT can create a model by which existing “big data” can be used to validate implants already on the European market.

However, the new MDR applies to all orthopaedic and trauma implants, not just total hip and knee prostheses and all of these are class 3 devices. Plates, screws, nails and braces, to name a few, fall under the new MDR. Orthopaedic, traumatology and cardiology surgeons are undoubtedly the health care professionals who implant the most device. However, many other implants used in other medical specialties also are regulated by the new MDR. Keep in mind the in vitro diagnostic regulation will be also implemented, although slightly after the MDR.

Uncertain future

My main concern is how the EU will manage such an undertaking, as well as the bottlenecks to the process that are inevitable, in the few remaining months until implementation. I wonder how companies whose products do not pass the clearance process will be affected and if that might result in fewer implants on the market and those that make it to or remain on the market will be more expensive. What implants will still be sold? Will manufacturers “remove” existing, well-proven and cheap implants and leave physicians to use just the new, less proven and more expensive products? Will there be product shortages as a result of this?

Several unanswered questions must be discussed further and evaluated in the coming months. However, one thing that is sure is the new MDR will be implemented next year and we must be ready when it is.

Disclosure: Kjaersgaard-Andersen reports no relevant financial disclosures.

The European Union Commission has launched a new medical device regulation for devices sold in the European Union that replaces the existing medical device directive. Under the new regulation, devices on the market are classified into one of three levels, with class 3 consisting of high-risk devices that need the strictest regulations.

Per Kjaersgaard-Andersen, MD
Per Kjaersgaard-Andersen

All orthopaedic and traumatology implants are class 3. A 3-year transition period from May 2017 until May 2020 was initiated to implement the new medical device regulation (MDR) system. It means that starting May 26, 2020, new implants introduced to the European market must comply with the new MDR. However, for some implants, the existing medical device directive (MDD) may remain in effect until May 2024, after which the MDR will be in the only device regulation in place.

Improved product safety

What does this mean for surgeons who practice orthopaedics and traumatology? The most visible benefit from the new MDR is that new implants introduced to the European market will have undergone a significant regulation process to improve safety for our patients, followed by strict post-market surveillance. Manufacturers claim this approach surely will result in fewer new products introduced to the market, a slower rate of new implant introduction compared to when other regional regulations are used and increased prices for the new implants.

That being said, innovation will never stop. New initiatives will appear. I am sure the manufacturers of medical devices that are now part of the European market slowly will adapt and maintain their current share of the overall orthopaedic and traumatology market.

On behalf of orthopaedic and traumatology surgeons in Europe and our patients, I welcome what the new MDR system means for products being introduced to the EU market because it will surely increase patient safety by reducing the risk of unexpected adverse events from implants and help avoid patient suffering.

Performance evaluation

However, implementation of the new MDR will affect products on the market now, as well as those that are just being introduced. Through the re-evaluation of implants that are already used in patients, the EU Commission aims to continuously validate all implants based on their performance and to potentially withdraw from the market those implants that fail to perform well in patients in the longer term. I also welcome this strategy for existing orthopaedic devices in the name of patient safety. However, it also concerns me. The new MDR for class 3 implants that are already on the market will require high-level, qualitative, clinical data to prove the safety of the implants. Although the level and amount of data needed for these products have not yet been published by the EU, I foresee a process that significantly increases product cost because it is possible that the manufacturers will need to deliver that data. This may result in the need for manufacturers to reduce the number of implants they sell, which may result in fewer implants that are available. Also, some smaller companies close because their products are no longer profitable for them.

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Some implants, such as total hip and knee prostheses, have more “big data” on their performance and survivorship available from high-quality national registries. Therefore, it is my hope the EU Commission, the notified bodies, the upcoming expert panels and EFORT can create a model by which existing “big data” can be used to validate implants already on the European market.

However, the new MDR applies to all orthopaedic and trauma implants, not just total hip and knee prostheses and all of these are class 3 devices. Plates, screws, nails and braces, to name a few, fall under the new MDR. Orthopaedic, traumatology and cardiology surgeons are undoubtedly the health care professionals who implant the most device. However, many other implants used in other medical specialties also are regulated by the new MDR. Keep in mind the in vitro diagnostic regulation will be also implemented, although slightly after the MDR.

Uncertain future

My main concern is how the EU will manage such an undertaking, as well as the bottlenecks to the process that are inevitable, in the few remaining months until implementation. I wonder how companies whose products do not pass the clearance process will be affected and if that might result in fewer implants on the market and those that make it to or remain on the market will be more expensive. What implants will still be sold? Will manufacturers “remove” existing, well-proven and cheap implants and leave physicians to use just the new, less proven and more expensive products? Will there be product shortages as a result of this?

Several unanswered questions must be discussed further and evaluated in the coming months. However, one thing that is sure is the new MDR will be implemented next year and we must be ready when it is.

Disclosure: Kjaersgaard-Andersen reports no relevant financial disclosures.