From OT Europe

EFORT symposium focuses on new MDR’s possible impact on orthopaedic practice, device innovation

The symposium showed the challenges of implementation, better transparency and data-led support for practitioners in the lead-up to the new MDR Implementation.
EFORT

With members of regulatory authorities and medical device providers sharing the stage at the EFORT Annual Congress, there were bound to be a few disagreements regarding the implementation or and consequences related to the new EU Medical Device Regulation, intended or otherwise. Moderated by former EFORT President Jan Verhaar and Professor Alan Fraser of the Biomed Alliance, the symposium provided insights into a variety of perspectives on the Medical Device Regulation, from the regulation’s focused intent to address patient safety to fears of stifled innovation on account of burdens on industry. Through each of the perspectives, the discussion regularly highlighted first and foremost the pre-eminence of patient safety and best patient outcomes as guideposts for the Medical Device Regulation, while also highlighting the impact on surgical practice and how the Medical Device Regulation might impact the work of orthopaedic surgeons across Europe.

The new Medical Device Regulation (MDR) replaces existing medical device directives and provides for a 3-year transition period from its passage in 2017. The new regulatory structure comes into force on May 26, 2020, and discussions and documentation provided by the European Medicines Agency and national competent authorities seek to provide guidance to stakeholders amongst both industry and practitioners to ensure a smooth transition to the new regulatory framework.

Move from directive to regulation

The MDR symposium at the EFORT Annual Congress in Lisbon was an opportunity for those who work with regulatory bodies and those who represent device manufacturers to share a stage with representatives of the EFORT membership, such as Professor Rob Nelissen, Chairman of the EFORT NORE Committee, and EFORT President, Associate Professor Per Kjaersgaard-Andersen, MD.

Tom Melvin of the Health Products Regulatory Authority gave an overview of why the MDR was necessary to implement, having resulted from 5 years of discussions in Brussels that took the contents of the MDR from being a series of directives to becoming an EU regulation, which is the highest order of legislation in Europe. The effort to move from directive to regulation was lobbied heavily by groups seeking transparency on the risks associated with some medical devices following several high-profile cases of persistent claims of dangers to patients. A group called the International Consortium of Investigative Journalists published an online database where the public can search devices for a list of related incidents or recalls.

The European Commission’s website now includes a Medical Devices section that provides journalists and the public with information on regulatory requirements and fact sheets with a goal toward creating a portal that emphasizes transparency for approved devices and questions of device safety and patient impact.

MDR to rely on clinical data

Nelissen highlighted the fact that clinical data is important for practitioners, and the new MDR’s reliance on clinical data, which will accrue across borders, will allow doctors to be better informed and provide optimal treatment for patients. He acknowledged that the portals and platforms are still far from their optimal form, but when put into place as envisaged by the MDR, the data-led initiative will provide a far greater public good than the perceived inconveniences to industry.

From the regulators’ perspective, Melvin indicated that there was a lot of strain on the regulatory bodies as well as the timeline and governance of the process to implement the new regulation by May 2020. Resources are tight, he said. This notion was seconded by Amie Smirthwaite, who spoke about the role of notified bodies, which, according to Smirthwaite, have a key role to play in transparency in the public’s interest. However, admittedly there is a lot of work to be done to implement the new regulations with scant resources, she said.

Manufacturers’ perspective

From the manufacturer’s perspective, Francesco Siccardi, CEO of Medacta, argued that burdensome regulation would require a slowdown in innovation that is at the heart of medical practice. He noted that the estimated turnaround of regulatory approval for updates to a device with substantial equivalence to a predicate device (ie, not subject to the premarket approval process) is 90 days in the United States and does not require FDA intervention. However, under the new MDR, with the involvement of European Union (EU) regulatory expert panels, the same process would require 7 to 10 months, thus having a substantial impact on competitiveness and innovation in the EU market. According to Siccardi, this would impact smaller companies more than larger companies that can better absorb the cost of delays, but would definitely impact the incremental innovation that is at the heart of the relationship between practitioners and manufacturers.

These differences in perspectives were not expected to be resolved in one afternoon’s symposium. With moderation from Fraser and Verhaar, the discussion provided an open dialogue amongst stakeholders on how to best implement the coming regulations in the one area where all parties vociferously agreed: patient safety is the number one priority in the eyes of regulators, manufacturers and practitioners alike.

EFORT

With members of regulatory authorities and medical device providers sharing the stage at the EFORT Annual Congress, there were bound to be a few disagreements regarding the implementation or and consequences related to the new EU Medical Device Regulation, intended or otherwise. Moderated by former EFORT President Jan Verhaar and Professor Alan Fraser of the Biomed Alliance, the symposium provided insights into a variety of perspectives on the Medical Device Regulation, from the regulation’s focused intent to address patient safety to fears of stifled innovation on account of burdens on industry. Through each of the perspectives, the discussion regularly highlighted first and foremost the pre-eminence of patient safety and best patient outcomes as guideposts for the Medical Device Regulation, while also highlighting the impact on surgical practice and how the Medical Device Regulation might impact the work of orthopaedic surgeons across Europe.

The new Medical Device Regulation (MDR) replaces existing medical device directives and provides for a 3-year transition period from its passage in 2017. The new regulatory structure comes into force on May 26, 2020, and discussions and documentation provided by the European Medicines Agency and national competent authorities seek to provide guidance to stakeholders amongst both industry and practitioners to ensure a smooth transition to the new regulatory framework.

Move from directive to regulation

The MDR symposium at the EFORT Annual Congress in Lisbon was an opportunity for those who work with regulatory bodies and those who represent device manufacturers to share a stage with representatives of the EFORT membership, such as Professor Rob Nelissen, Chairman of the EFORT NORE Committee, and EFORT President, Associate Professor Per Kjaersgaard-Andersen, MD.

Tom Melvin of the Health Products Regulatory Authority gave an overview of why the MDR was necessary to implement, having resulted from 5 years of discussions in Brussels that took the contents of the MDR from being a series of directives to becoming an EU regulation, which is the highest order of legislation in Europe. The effort to move from directive to regulation was lobbied heavily by groups seeking transparency on the risks associated with some medical devices following several high-profile cases of persistent claims of dangers to patients. A group called the International Consortium of Investigative Journalists published an online database where the public can search devices for a list of related incidents or recalls.

The European Commission’s website now includes a Medical Devices section that provides journalists and the public with information on regulatory requirements and fact sheets with a goal toward creating a portal that emphasizes transparency for approved devices and questions of device safety and patient impact.

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MDR to rely on clinical data

Nelissen highlighted the fact that clinical data is important for practitioners, and the new MDR’s reliance on clinical data, which will accrue across borders, will allow doctors to be better informed and provide optimal treatment for patients. He acknowledged that the portals and platforms are still far from their optimal form, but when put into place as envisaged by the MDR, the data-led initiative will provide a far greater public good than the perceived inconveniences to industry.

From the regulators’ perspective, Melvin indicated that there was a lot of strain on the regulatory bodies as well as the timeline and governance of the process to implement the new regulation by May 2020. Resources are tight, he said. This notion was seconded by Amie Smirthwaite, who spoke about the role of notified bodies, which, according to Smirthwaite, have a key role to play in transparency in the public’s interest. However, admittedly there is a lot of work to be done to implement the new regulations with scant resources, she said.

Manufacturers’ perspective

From the manufacturer’s perspective, Francesco Siccardi, CEO of Medacta, argued that burdensome regulation would require a slowdown in innovation that is at the heart of medical practice. He noted that the estimated turnaround of regulatory approval for updates to a device with substantial equivalence to a predicate device (ie, not subject to the premarket approval process) is 90 days in the United States and does not require FDA intervention. However, under the new MDR, with the involvement of European Union (EU) regulatory expert panels, the same process would require 7 to 10 months, thus having a substantial impact on competitiveness and innovation in the EU market. According to Siccardi, this would impact smaller companies more than larger companies that can better absorb the cost of delays, but would definitely impact the incremental innovation that is at the heart of the relationship between practitioners and manufacturers.

These differences in perspectives were not expected to be resolved in one afternoon’s symposium. With moderation from Fraser and Verhaar, the discussion provided an open dialogue amongst stakeholders on how to best implement the coming regulations in the one area where all parties vociferously agreed: patient safety is the number one priority in the eyes of regulators, manufacturers and practitioners alike.