As a customer-centric organisation with decades of experience in the medical field, Avery Dennison Medical has the expertise in-house to offer customized regulatory guidance, ranging from support with international registrations to overseeing full regulatory compliance.

Medical Device Regulation (MDR) explained

The Medical Device Regulation (MDR) is the result of the European Union’s effort to renew and sharpen the previously introduced Medical Device Directive (MDD). Compared to the latter, the MDR is a much broader document, containing supplementary requirements and mandatory jurisdiction, directly applicable and enforceable in all EU Member States. 

Understanding the significance of quality and safety in the medical field, Avery Dennison Medical puts everything in place to comply with all appropriate MDR regulations. 

We also offer medical OEMs, converters, and start-ups, regulatory support for MDR compliance, adapting to each situation and challenge.

FDA approval for medical adhesives and tapes

A 510(k) is a premarket submission made to the FDA, the US equivalent of the European CE-mark, to demonstrate that a medical device is safe and effective. Each person who wants to market in the United States a Class I, IIa, and IIb medical device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to the FDA unless the device is exempt from 510(k) requirements.

Medical devices can sometimes be exempt from 510(k) submission, depending on the product’s claims, or if the product is an unfinished device or component sold to another company for further processing or assembling.

Safety and Audits

Avery Dennison Medical’s finished products are audited on a regular basis by an external notified body, ensuring they meet all quality and safety standards, a prerequisite to maintaining their CE-marking and FDA-approval. 

Our regulatory experts may provide material safety data sheets, as well as biocompatibility and REACH certificates, that qualify Avery Dennison Medical’s rolled goods and components. These evaluation documents may serve as an input for FDA and MDR compliance applications for finished medical products that are developed by our customers.

Consult our ISO, MDD, MDR and FDA certificate section here.

What are the ISO 13485 requirements for medical devices

ISO 13485 is a harmonized standard for medical device manufacturers requiring the implementation of a quality management system. Companies that are involved in one or more stages of the life cycle, need to demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations. For more information, visit iso.org.

The ISO 13485 requirements are very much aligned with the Good Manufacturing Practices (GMP), the quality system required by the FDA for products within the food, drugs, biologics and devices industries. Despite the fact that both serve the same purpose, the GMP is a set of regulatory requirements that are mandated by law, to ensure that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. For more information, visit ispe.org/gmp-resources.