Thomas is an expert in Supply Chain and Manufacturing Optimization with more than 10 years of experience originating from Medical Device and High-Tech & Electronic Industries. He comes with a background as an Electronics engineer, complemented with a Master in Technology Management. Thomas has held positions in multinational corporations such as Nilfisk, heading the internal optimization program as well as the supply chain organization.
EU MDR will be making life hard for small and medium medical device manufacturers
Meeting EU MDR requirements before the deadline will be hard for most smaller and medium medical device manufacturers, industry expert foresees. The new regulations are creating huge obstacles for both regulatory authorities and the industry.
The new EU MDR will put additional administrative and financial strain on medical device manufacturers, and according to Christoph Manegold, it will hit smaller and medium-sized manufacturers especially hard. Christoph Manegold is partner counselor at AC Controls in Germany and initiator of the federal network MDR Competence.
“It all comes down to the new requirements on clinical evaluation and clinical studies. In short, the process of declaring some sort of equivalence to existing and new devices will be very complex. That is going to become a major burden for every medical device manufacturer operating in Europe,” says Christoph Manegold.
He refers to the fact that the MDR will require all current products on the market to undergo a new conformity assessment. As grandfathering is not allowed, any device not certified into the MDR by the end of the transitional period can not be placed on the market any longer.
Due to severe patient incidents with medical device products in Europe, including the hip replacement and breast implant scandals, there has been frequent calls for tighter regulation with medical device products in Europe. That has led to the Medical Devices Regulation (EU MDR), which took effect on 25th May 2017 and after a three-year transition period, will become mandatory in all EU member states.
Increased requirements for clinical studies
Under the old Medical Device Directive, it was possible to cover the proof of benefit with simulations or written documentation. The main concern back then with the certification of medical devices was patient safety, so the focus on as to whether a product worked as described, was given lower priority. But under the new MDR regulations, re-certification will now require a clinical study.
“The MDR is really forcing organizations to re-establish clinical testing, clinical evaluation, trials and documentation. Article 61 of the MDR says, that in order to be able to quote a third-party device as being equivalent to your clinical evaluation, you have to ask your competitor to grant you access to his technical documentation, his entire IP, his entire device documentation to be able to quote his device as being comparable to your device,” says Christoph Manegold and continues:
“Show me a competitor who is willing to do that! You are basically asking for free competitive data. In my experience, no competitor is willing to release that kind of data. In real life, this is an impossible situation if companies want to avoid clinical studies,” says Christoph Manegold.
Clinical studies also required for existing products
Older devices that have proved their value already, will also have to go through clinical studies before they can enter the European market once the EU MDR is fully implemented. This is an even bigger hurdle, according to Mr. Manegold.
“Clinical data may have to be supplied even for devices that have never been involved in any accidents. And if the manufacturers cannot do this according to MEDDEV 2.7.1 via documentation only, then in a worst-case scenario the legislator is forcing them to carry out studies for a device which has been around for several decades,” says Christoph Manegold.
The entire industry will be put under financial strain
As Mr. Manegold points out, smaller and medium-sized companies are not prepared for this.
“What happens is that these companies will have to restructure their organization in a way that the organization is able to fulfill the administrative challenges. Because the consequence of this administrative burden is that smaller and medium-sized businesses are forced to shuffle staff from R&D and Product Development and move them into Regulatory and Quality.,” says Christoph Manegold.
On a larger scale, he estimates that the entire healthcare system will be put under additional financial strain after the end of the transition period, with additional costs running up to 10-15% for medical devices, depending on risk category and quantity.
“Smaller and medium-sized manufacturers do not have the staff for this nor the expertise. And the authorities do not have the resources to scrutinize and monitor all these studies simultaneously, not even to mention the additional costs involved,” says Christoph Manegold.
The advice to smaller and medium-sized medical device manufacturers
Christoph Manegold does not foresee the demise of small and medium-sized medical device manufacturers across Europe, but he does expect an increase in mergers and acquisition activities.
To avoid being swallowed by bigger players in the industry, he advises smaller manufacturers with similar products to cooperate in networks.
“In Baden-Württemberg for instance, a large group of smaller medical device companies has created a common clinical competence center to jointly finance the cost for a physician to carry out clinical studies. Smaller and medium medical device companies should avoid fighting about each other’s IP and instead look to areas where it will make sense to cooperate,” he says.