Technologies and industries are merging all around us. We are seeing watches become medical devices and former clinical care and equipment being moved into the home. Regulators are responding by introducing new Guidance and updating requirements. It is the responsibility of the product owners to not only understand the current requirements, but anticipate and plan for upcoming changes to the requirements that may eventually affect their ability to sell products. In this issue of Ask the Expert, UL experts respond to questions about both existing and future requirements.
Q: What is the impact of the European Council’s vote to move forward with its approach to new medical devices and in vitro diagnostics (IVD) legislation?
A: Current changes include an expanded scope of regulated devices, greater oversight and control of notified bodies, unannounced audits of suppliers and more. For most medical device manufacturers, these changes will directly impact the product review and certification process, and are likely to increase the investment of time and resources required for product approval. In addition, the IVD legislation opens up regulatory controls over many IVD products that were previously not required to be under Notified Body regulatory oversight, such as some cardiac and cancer biomarkers and more. You can read more about the impact of the new UE Medical Device Regulations at: http://library.ul.com/?document=the-changing-landscape-of-medical-and-in-vitro-diagnostic-device-regulations-in-the-european-union
Q: We produce products that are used in medical day spas. Are these required to have FDA approval and UL Certification?
A: With an aging population that is living longer and healthier, in combination with advances in technology that help people look and feel younger, there is an increased demand for these kinds of Beauty Therapy or “Beauty Care” products and procedures. Many of these products are also available for home use. Depending on the product and the marketing claims, some fall under FDA regulatory authority and others do not. The requirements in other countries are also dependent on the product type, its technology and marketing claims.
OSHA generally requires all products used in the workplace to be certified to recognized standards. You can read more on the standards that apply to Beauty Therapy products in the UL white paper at: http://library.ul.com/?document=safety-of-personal-hygiene-beauty-therapy-equipment-used-in-commercial-settings