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Proposed EU standard for stricter medical device approval could prove challenging
The European Union may be moving toward stricter medical device regulations following an implementing act issued in September 2013 by the European Commission. New legislation has been proposed to make approval laws for medical devices the same in all European Union regulatory bodies, and if approved, it will take effect in 2017.
If approved, the new uniform approval process for medical devices will also add time — possibly multiple years — to the approval of a new product, but it would also keep defective products off the market because additional clinical data would be required for approval and this may lead to increased patient safety, said sources interviewed for this article.
“A major weakness in the system is there is not much need to demonstrate clinical efficacy or even safety, beyond complying with the (Medical Devices) Directive’s requirements,” Andrew S. Thompson, PhD, a senior medical diagnostic analyst at GlobalData Healthcare, a global research and consulting company, told Orthopaedics Today Europe.
Toward a uniform process
The self-certification nature of the current process means it is quicker for manufacturers to get a device onto the market. Companies did not have to go through years of what “might be perceived as onerous testing,” Thompson said.
However, if the new regulations are approved, it may lead to increased costs of medical devices in Europe, according to Thompson. “If the approvals process becomes longer and more complicated, it is bound to increase the cost of development. It is probably not going to make medical devices any cheaper in Europe and it is not clear how much of that increased cost will be passed on,” he said.
Currently, to obtain a European CE mark or Conformity Assessment for a new medical device, a company submits an application to one of 75 EU Notified Bodies, a certification organization designated by the national authority of a member state. The Notified Body will see if a medical device company’s application for a new product is approved by a Conformity Assessment, which examines a potential device’s design, full quality assurance, product quality assurance and other qualifications.
If the Declaration of Conformity was granted by one notified body to a medical device, it could be sold throughout the entire European community. However, according to John Wilkinson, chair of the Competent Authorities for Medical Devices (CAMD) group at the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, “Many of us thought that this was an unsatisfactory situation because it leaves a lot of room for different interpretations of the rules. Potentially, it mean that Notified Bodies in different countries were operating with slightly different standards.”
If the new legislation is approved by the European Parliament, Notified Bodies would go through a full re-designation process by a joint audit including the European Parliament, the competent authorities of the member state and two other member states to bring all Notified Bodies under the same set of rules.
“The end result will be, we hope, a much more consistent performance both by member states and the Notified Bodies. The idea is to bring this into one system operating consistently via a very clear set of rules,” Wilkinson said.
Patient safety may improve
Overall, if the new device regulations are approved, orthopaedic surgeon Aare Märtson, MD, PhD, Head of Department of Traumatology and Orthopaedics of University of Tartu, and Clinic of Traumatology and Orthopaedics of Tartu University Hospital in Estonia, who is president of the Nordic Orthopaedic Federation, said he could see patient safety improving overall throughout Europe. It would make the European system more on par with the U.S. Food and Drug Administration (FDA), in terms of the regulation and approval process for medical devices.
“Right now, it is much easier for a medical device to be approved and be put on the market than it is for a new drug to be approved and put on the market in Europe,” Märtson said.
“I think a centralized regulatory agency could improve patient safety, and as I understand the FDA regulations, they are much harder than Europe,” he said. “The European market is not very open, but the regulations are easier than in the United States.”
Need for greater confidence
Increased transparency for the Notified Bodies, medical device companies, and all facets of the approval system would help increase patient and buyer confidence when it comes to devices in Europe, Eric H. Garling, PhD, Director Medical & Scientific Affairs Europe at Stryker in Amsterdam, told Orthopaedics Today Europe. With the metal-on-metal issues and other faulty devices that created adverse health effects in the past few decades, he said patient confidence in the medical device market was shaken.
Therefore, it makes sense to have a centralized regulatory process and uniform regulation across Europe in the field so medical device manufacturers know what to expect, Garling said.
“It is important for us as manufacturers to gain back the confidence of our patients. The industry treats patients, makes them better and they need to trust the products they receive. That should be the basis, of course. Definitely, there are ways to improve the confidence. There have been suggestions by the European Commission (EC) for more transparency, more for the patients, buyers and surgeons, for everyone; hopefully it will indeed help there,” Garling said.
The central database being discussed might help organizations see the kinds of trials conducted to show the safety and effectiveness of our products, and the results will be and should be published. That will hopefully restore the confidence of our customers, patients and surgeons, he said.
A decrease in innovation
One potential drawback of the new process, however, would be a slowdown in innovation in the medical device field as it would take longer for products to reach the market and increase costs for companies to develop them, according to Garling.
“It will take longer to have an innovating product available for all patients and markets. There will be a delay and there will be financial burdens. I think it will slow down innovation,” he said.
The new process, if approved, will most certainly increase the amount of time it takes for a new device to come onto the European market. It will decrease innovation and will affect market growth in the future, Konrad Kobel, vice president of quality management at Aesculap, in Tuttlingen, Germany, said.
The mandatory clinical trials for high-risk devices and implants will be time consuming and expensive, he said, and noted that innovation may be negatively affected by the new stricter regulation process, as well.
“Based on the stricter approval process, new innovations will have no chance to reach patients or go to the market in the pace as in the past. I also believe that many small- or medium-sized companies will probably not invest anymore in new innovations based on the hurdles they face with the stricter approval process, scrutiny procedures for high risk devices, as well as mandatory clinical trials for certain devices,” Kobel said.
More bureaucracy possible
In addition, after implementation of the proposed regulations, medical device companies will have additional work, administrative tasks and the need for more involved resources to have high-risk products and implants approved by the EC, Kobel said.
“The reasons are the additional scrutiny procedure, the additional mandatory clinical trials and increased documentation,” he said.
For hospitals that already take a conservative approach to the medical devices they use, Märtson said there may not be much of a change if the new clearance system is approved.His institution currently uses devices that are fairly conservative and would likely be passed even with the new process, he said.
“It will not have a big influence on my patients because we have been very conservative. I am coming from a small country. We are following Scandinavian traditions, so if you take joint implants, at least what we use in my hospital, we use very well-approved things,” he said. “Although, I think patient health would improve overall. Everyone is familiar with this metal-on-metal hip joint prosthesis disaster. So that is why I think it is important to make this regulation process much harder than it has been,” Märtson said.
It is a controversial issue because innovation, development and patient safety have to be considered for all the devices, he said and noted that perhaps a moderate solution could be found that is better than the current system but does not negatively influence device development and innovation.
Patient safety may improve
If the new CE mark approval system is passed, the process to have an item approved for the general market will become more expensive and more time consuming, Linda Tian, medical devices analyst at GlobalData Healthcare, told Orthopaedics Today Europe.
Tian said most orthopaedic implants are class III products, for which many of the newly proposed changes to the regulations would apply, and some negative impact on the orthopaedic market must be expected.
“It is too early to jump to conclusions at this stage, especially when we do not know how the proposals will be fine-tuned and when these proposals will be finalized. In the next 3 years, we will not see any significant slowdown in product launches in Europe,” she said. “However, in the longer term, the CE marking process is very likely to be more expensive and slower. In terms of innovations, we will continue to see that from the industry, but it is likely these innovations will be in terms of new business models rather than technical breakthroughs.”
Regulations may affect the economy
Tian said the current economy of Europe is not helping the medical devices market and any increased regulations and time for approval may hurt it even more.
“The economic softness lingering in the Eurozone is already slowing down the growth of some orthopaedic segments, particularly large joint replacement and spinal fusion. An unpredictable framework will probably further dampen companies and investors’ enthusiasm,” she said.
If passed, the proposal from the MHRA to change the approval process for medical devices will make the process more transparent and easier for all parties involved, Wilkinson said.
“Our proposals are designed to make the approval process more precise and more transparent, not unduly burdensome. They retain the fundamentals of the system that has been around for the last 20 years,” Wilkinson said. “There have been voices in the Parliament who have proposed a move toward a more centralized premarket approval, similar to the FDA process, but that is not the direction that we think would be wise or helpful.” – by Robert Linnehan and Michela Cimberle
- References:
- Commission implementing regulation (EU) No 920/2013 of 24 September 2013. Official Journal of the European Union. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:253:0008:0019:EN:PDF.
- Medicines and Healthcare Products Regulatory Agency. Notified Bodies. http://www.mhra.gov.uk/Howweregulate/Devices/NotifiedBodies/index.htm. Modified July 15, 2014. Accessed Sept. 3, 2014.
- For more information:
- Eric H. Garling, PhD, can be reached at Stryker EU Operations B.V., Herikerbergweg 110, 1101 CM Amsterdam, Netherlands; email: eric.garling@stryker.com.
- Konrad Kobel can be reached at Aesculap AG, Am-Aesculap Platz, Tuttlingen, Germany 78532; email: konrad.kobel@aesculap.de.
- Aare Märtson, MD, can be reached at Tartu University Hospital, Department/Clinic of Traumatology and Orthopaedics, Puusepa 8, Tartu 51014 Estonia; email: aare.martson@kliinikum.ee.
- Andrew S. Thompson, PhD, and Linda Tian can be reached through GlobalData Healthcare’s press office at Knowsley House, Knowsley St., Bolton BL1 2AH, United Kingdom; email: pr@globaldata.com.
- John Wilkinson can be reached at MHRA, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, UK; email: nicholas.spears@mhra.gsi.gov.uk.
Disclosures: Garling is the Stryker Europe director of medical and scientific affairs. Kobel is the Aesculap vice president of quality management. Märtson receives royalties from W. Link (Link Academy) for providing education programs and receives royalties for lectures and grants for travel from DePuy/Johnson & Johnson. Thompson is a senior medical device analyst at GlobalData Healthcare. Tian is a medical device analyst at GlobalData Healthcare. Wilkinson is the Chair of the CAMD at the MHRA.
Is it desirable for Europe to have a centralized regulatory approval process based on scientific evidence, similar to the FDA process, or is speed of approval valued over risk?
Approval speed not valued over risk
The EU system for approving medical devices has come under criticism because of the number of approved devices which have turned out to be dangerous. In the United States, sufficient valid scientific evidence in humans is required which shows high-risk devices are both safe and effective. In Europe, however, approval of medical devices is conducted by private for-profit companies and based on much more limited evidence. Often there are no significant studies in humans required to show these devices are safe. There is no absolute requirement that medical devices provide an actual treatment benefit to patients.
The problems with metal-on-metal hip implants have shown that the regulatory process in Europe is not sufficient. The British Medical Journal even showed it was possible to get EU approval for an ASR type prosthesis, an implant which was taken from the market a year before because of a high rate of revision. Many people in Europe believe medical technologies are being introduced to the commercial market without sufficient high quality evidence for improved benefits over existing implants. Where drugs must be compared to other drugs, this kind of research is hardly available for orthopaedic implants.
For that reason I believe the orthopaedic community should support a centralized regulatory approval process for orthopaedic implants in Europe which is similar to the FDA in the United States. It would be preferable to join forces and design an identical approval process. Scientific evidence based on comparison between new implants and existing implants with well- known good results should be generated. The whole process should be public and all supplied material in the approval process should be available for the public.
Speed of approval should not be valued over risk. Orthopaedics has built up a good reputation with many high quality implants with enormous benefits for society. We will lose that good reputation when we do not choose for a careful step-by-step process to improve our care further by allowing even better implants. The business life cycle of good orthopaedic implants should be extended to raise money for research for real improvements and to prevent the introduction of new disastrous implants for our patients.
Jan A.N. Verhaar, MD, PhD, is an Orthopaedics Today Europe Editorial Board Member. He is a Professor of Orthopaedics and Chair of the Department of Orthopaedic Surgery at Erasmus University Medical Center, in Rotterdam, The Netherlands.
Disclosure: Verhaar has no relevant financial disclosures.
Change is needed in Europe
I would say definitely yes, it is desirable for Europe to have a centralized regulatory approval process based on scientific evidence. To have a more thorough evaluation, to have a more equal deliberation process, and to have the knowledge in one office would be good instead of how it is today where there are around 80 to 90 different bureaus involved in device clearance.
I would say that a one zone, political body regarding approval of implants in Europe is also good.
However, I think it also depends on if you can actually make your own conclusions from the directive changes out there now. There is a risk of that if they draw their own conclusions on how to regulate implant approval, which I believe is a problem. You need equality in the approval process and it also needs to be an organized approval process.
Søren Overgaard, MD, DmSc, is a Professor and Head of Research at the Department of Orthopaedic Surgery and Traumatology at Odense University Hospital, in Odense, Denmark.
Disclosure: Overgaard receives grants from Biomet DK and Biomet, DePuy, Protesekompaniet and Zimmer. He is a principal investigator for Eli Lilly.