Navigating the global regulatory landscape can be confusing for anyone in the life-sciences realm, including manufacturers that make wearable sensors and other medical devices. To that end, Trelleborg Healthcare and Medical is offering manufacturers that supply such products to European clients resources (including a free webinar) geared toward helping them understand and comply with the Medical Device Regulation (MDR), which goes into effect May 26.
The new MDR is intended to help protect patients from risks that may be posed by a range of medical products. Florance Veronelli, segment manager with Trelleborg Sealing Solutions, talked about the assistance offered by the firm, and what the regulation means for the industry.
OSP: Could you please share an overview of Trelleborg—who you are, what you do, key capabilities, and what sets you apart?
FV: Trelleborg Healthcare and Medical partners with customers to design, develop, prototype, manufacture, and bring to market innovative engineered solutions for demanding medical device, biotech and pharmaceutical applications.
Our unique combination of capabilities, including molding, extrusion, drug combination devices and more, enable us to provide creative solutions to our customers’ design and manufacturing challenges. Our 30+ year track record of superior support, reliable supply, and world-class quality, gives customers confidence that they can rely on us for all stages of the manufacturing process.
OSP: In general, how challenging has it been for medical device manufacturers to keep up with global regulations affecting their products?
FV: For medical device manufacturers, worldwide regulations are a constant challenge. The top priority for a medical device manufacturer should be patient safety. To ensure this, standards, regulations, and laws have been passed. However, these regulations vary from country to country.
If a medical device manufacturer wants to sell its products worldwide, its products must meet all the requirements for the country it is selling to. The requirements apply to all phases of product development, including design, material selection, clinical studies, regulatory approval, commercialization, and post-commercialization product monitoring. Extensive documentation is required throughout the process. Some regional laws and regulations are becoming even stricter, and meeting these requirements for existing and new products is an even greater challenge.
OSP: Could you please explain the MDR regulation, and how it impacts manufacturers?
FV: The MDR ensures compliant medical devices for the European market. The MDR takes effect on May 26, 2021 replacing all European regulations. The aim is to ensure a uniform standard for medical devices throughout Europe. For manufacturers in the Americas selling such products to Europe, compliance with the new regulations is a challenge, as requirements have become more stringent and depend on the intended use, patient contact, and the duration of product use.
Medical device manufacturers now need to look more intensively at material selection, the conformity assessment process, and post-market surveillance. Depending on the application and material selection, the medical device class may also change.
OSP: Does the new reg impact any type of device or therapy area more than another?
FV: The requirements, and especially the regulatory burden, vary greatly depending on the medical device class. For class I devices, no conformity assessment procedure is needed. The higher the medical device class and the application risk, the higher the documentation and testing effort.
As a result of the MDR, some class I products have been upgraded to class II, which has led to enormous challenges for medical device manufacturers.
OSP: What types of information and resources does Trelleborg offer that could help companies comply?
FV: The new requirements involve a detailed knowledge of the material ingredients, such as endocrine disruptors, carcinogenic, mutagenic and reproductive toxic substances (CMR-substances) and nanomaterials.
As an expert in polymer components for medical technology, Trelleborg’s materials are developed and tested to ensure they meet specific regulations, including MDR. Strategic materials for medical technology continue to be reviewed in accordance with the requirements from the MDR, and extensive testing is carried out on cross-linked material. Trelleborg can provide targeted support in selecting the right material for a specific application.
In addition, to complying with the MDR's basic principle of maximum patient safety, Trelleborg Healthcare & Medical has implemented a quality management system in accordance with ISO 13485 and takes a risk-based approach to managing its processes.
We recently conducted a webinar called "Tackle MDR requirements with your supplier's material expertise." In this webinar, Trelleborg and other industry experts explain the material-related requirements of the MDR and how to achieve them. Tore information can be found on our website.
OSP: Can you share a specific example of the Trelleborg team helping a manufacturer get their wares in line with the MDR regulation?
FV: Immediately after the announcement of the new MDR requirements, Trelleborg worked closely with a number of manufacturers to ensure compliance. One example of this is with a long-standing ventilation customer.
Together we analyzed the material-related requirements and qualified our materials for its application. This included extraction tests in an application simulation. Through these tests, we were able to prove that the materials could be used for our customer's application and that the customer was prepared for the MDR at an early stage. This example also shows that it is important for the component manufacturer to understand the application, as material tests are highly dependent on the application.
OSP: What advice do you have for companies looking to make sure their products are less susceptible to shifts in regulatory requirements?
FV: Engage in an open exchange with your suppliers early on so important requirements can be considered at the development stage. This ensures optimal support for mechanical properties, component manufacturability, and scalability.
In addition, regulatory requirements arising from various standards and laws can be incorporated into the material selection, thus ensuring material compliance.
