EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of RDC 546-2021 testing. This new RDC 546/2021 resolution replaces the old RDC 2001 released in 56. Effective October 1, 2021, manufacturers and importers of healthcare products must comply with the essential safety and efficacy requirements described in this regulation.
Taking into account the intended use of the product, medical devices should be designed, manufactured and packaged in a way that minimizes the risk of contamination and waste for patients as well as persons involved in transport, storage and use.
Medical devices must be designed and manufactured to be completely safe for use with materials, substances and gases to which they are exposed during normal use and routine operations. If medical devices are used for drug administration, these products must be designed and manufactured in accordance with the drugs contained in the regulations and restrictions on these products, and their use must be permanently adapted to their purpose.
Healthcare products and manufacturing processes must be designed to eliminate or reduce the risk of infection to patients or consumers, operators or relevant third parties.
Medical devices supplied in sterile condition must be designed, manufactured and packaged in non-reusable packaging or according to appropriate procedures to be sterile at the time of sale and to maintain that condition under foreseeable storage conditions.
Packaging systems used for non-sterile medical device products must maintain the product in its intended clean condition intact and minimize the risk of microbial contamination if the product must be sterilized prior to use.
EUROLAB assists manufacturers with RDC 546-2021 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
