The new EU Medical Device Regulation (MDR) will soon be coming into effect and with two months to go the countdown is on for businesses within the medical devices field to conform. The implementation of this regulation has been designed to provide Europe with a competitive advantage by demonstrating high standards of qualitative compliance.
Samantha Knowles, Director of Research at Laurence Simons Search interviews Anne-Sophie Bricca, Deputy General Counsel - Senior Director Legal Affairs and Compliance, at Terumo BCT on what they are doing as a business to meet the 26th May 2020 deadline.
Samantha Knowles (SK): The new medical device regulation will be coming into effect in May 2020. How familiar are you with the provisions of the MDR?
Anne-Sophie Bricca (ASB): I am very familiar with these provisions as our Law Department has to support the implementation of the MDR in our company. I benefitted from many educational sessions provided by Medtech Europe so I do have a good level of understanding of this regulation.
SK: Will this affect your business and how?
ASB: Yes, this will affect our business as Terumo BCT is a medical device company that manufactures and sells medical devices within the European Union. Our Quality Management System was mainly based on the US regulatory standards (FDA) as our headquarters is based in Denver, Colorado. To be compliant with the EU MDR we had to review all our processes and ensured that they fully comply with the MDR. Fortunately, our historical notified body has been designated by the European Commission and all our files are up to date.
SK: Do you see this as a positive change?
ASB: Yes, it is definitely a positive change. Our industry has been exposed to criticism in the past due to the fact that the medical device industry was less regulated compared to the pharmaceutical industry. There have been scandals and most famously the breast implant scandal (PIP) which highlighted some deficiencies in the control system under the medical device directive. The reinforcement of the role of the notified bodies as well as the development of a post-market surveillance will reinforce the risk management system related to the commercialization of the medical devices.
SK: What does this mean for you?
ASB: I see it as a reinforcement of the quality and safety of the medical devices and mitigation of the risks related to the implementation and use of medical devices in the EU market. Consequently, this is a good thing even if it represents a significant cost of investment for the companies.
SK: What challenges, if any, has this brought?
ASB: The main challenge for Terumo is the risk of reclassification of certain medical devices. Under the MD regulation medical devices are classified according to the level of risk they may generate on the human body. So, you start with class 1 which presents the minimum potential to harm the user up to class 3 for the devices which require much longer clinical evaluation and more documented technical files before being authorized to be distributed on the market. The EU Commission guidance document relating to the classification has not been published yet and this is problematic. There is still some uncertainty on whether some of our products may have to be up-classified. The registration of an up-classified device will require additional clinical data which means time and resources.
SK: As part of the new regulation companies now need a Person Responsible for Regulatory Compliance (PRRC) such as a Quality Manager. Do you have an employee who already holds these responsibilities or has internal mobility or external recruitment been required?
ASB: There is a new parallel to make with the Data Protection Officer under GDPR. Each time there’s a new European regulation we see there is a need for a fulltime resource dedicated to supporting this activity. For the PRRC (Person Responsible for Regulatory Compliance), the role will be assumed by our Quality Director as this is the person in charge of all quality management systems. For bigger companies, it may be a fulltime job which will require new hiring. In Terumo, we usually try to promote somebody internally as it’s always easier to train somebody who is already aware of how internal systems operate. Nevertheless, it’s still difficult to comprehend today what will be the exact role and responsibility of this PRRC position and we may expect that it will take further importance in the midterm.
SK: How will this affect Legal?
ASB: The contribution of the Law Department in the implementation of the MDR, aside from general advice on the interpretation of the regulation and on risk mitigation, has been to update all our agreements with our different stakeholders (authorized representative, importer, distributor) to ensure the list of obligations imposed by MDR are well-reflected. In particular, all these partners shall comply with the regulation and report complaints and suspected serious incidents, if any. In the future, in case of issues, it will facilitate the identification of the chain of responsibility and of the level of liability of each stakeholder.
Please note that the EU Commission recently announced it is working on a proposal to postpone the date of application of the MDR for one year to relieve pressure from national authorities, notified bodies, manufacturers and other actors and will allow them to focus fully on urgent priorities related to the coronavirus crisis.