Company insight
The compliance countdown: Are you ready for the new MDR?
Kathleen Jacobs, global regulatory affairs director biomedical, Rousselot, on how to choose the right biomaterial to ensure compliance with the new European Medical Device Regulation.
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n the rapidly changing landscape of modern medicine, biomaterials have emerged as essential components in a wide range of medical devices. From implants to diagnostic tools, these materials play a crucial role in transforming healthcare. Yet, often neglected is the vital part that choosing the right biomaterial can play in navigating the regulatory landscape. With the end of the transition period for full implementation of the European Medical Device Regulation (MDR) in sight, medical device manufacturers must act now to ensure they are using biomaterials that will enable them to remain compliant with the new regulations.
Recent developments in regulation for medical devices Biomaterials are materials that are specifically designed to interact with the body. They need to exhibit high biocompatibility and purity to ensure they do not provoke adverse reactions. Regulatory bodies such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) impose stringent requirements to ensure patient safety and product efficacy. Compliance with these regulations is a fundamental requirement for medical device manufacturers. In particular, the European MDR, which became applicable in May 2021, and the EU In Vitro Diagnostic Medical Device Regulation (IVDR), which became applicable in May 2022, represent a significant shift in regulations for medical devices. These regulations place a premium on patient safety, necessitating rigorous documentation, quality assurance and product performance assessments.
throughout the entire product development process, from R&D to regulatory filing.
Kathleen Jacobs, Global regulatory affairs director biomedical, Rousselot
A transition period for full
implementation of the legislation has been set in place, ending on 26th May 2024 for the MDR. Meanwhile, the IVDR transition phase ranges from May 2025 to May 2028, depending on the class of device. Despite important progress in the implementation of the regulation, many manufacturers are not sufficiently prepared to meet the robust requirements of the MDR by the end of the current transition period. This could pose a threat to the availability of medical devices on the EU market.
Navigating the new regulatory landscape
Rousselot, a leading provider of purified biomaterials, recognises the paramount importance of regulatory compliance in bringing high quality, safe medical device and pharmaceutical formulations to the market. Rousselot’s X-Pure, Quali-Pure gelatins and modified gelatins are specifically designed to support compliance with the most recent medical device regulations. All Rousselot products come with: ■ Supporting documentation for compliance of medical devices with the new MDR requirements ((EU) 2017/745)
■ Documented traceability up to the farm (ISO 22442-2)
■ Validated viral inactivation (ISO 22442-3) ■ IPEC GMP Compliance
Rousselot’s expert technical team is available to support manufacturers
Medical Device Developments /
www.nsmedicaldevices.com
The role of purity in shaping the future of medical devices On top of the MDR, certain medical devices and pharmaceutical applications may be subject to additional endotoxin limits, depending on the route of administration, amount of product used and where the device is used in the body. For example, the FDA limit on the endotoxin levels of medical devices exposed to the central nervous system via cerebrospinal fluid is 2.15 endotoxin units per device (EU/device), or 0.06 EU/ml. By starting with biomaterials that already meet stringent purity requirements – such as Rousselot’s ultra- purified X-Pure range – manufacturers can ensure that they not only perform their intended functions effectively but also limit the foreign response in in-body applications or limit the impact of endotoxins in in-vitro diagnostics. By reducing the likelihood of required rework in pre-clinical or even clinical investigations, the use of purified biomaterials early on in development could not only save time but also can minimise costs associated with extensive quality control measures and potential product recalls.
As we continue to navigate new biomedical applications and the associated regulatory requirements, the importance of choosing the right biomaterial cannot be underestimated in the quest for medical device manufacturers to accelerate their products to market. ●
www.rousselot.com 115
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