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  • Feature ArticlesFeature Articles

    CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation

    This article explains the revised classification rules, conformity assessment procedures and new requirements for clinical evidence to support the safety and performance of an In Vitro Diagnostic (IVD) medical device. Of significance, the In Vitro Diagnostic Device Regulations (EU 2017/746) transition from the prior two class system under the IVD Directive (98/19/EC) to a four-class, risk-based classification system. 1 The regulations, intended to affect greater IVD saf...
  • Regulatory NewsRegulatory News

    What to do if a Device Manufacturer’s Notified Body Halts Operations? France’s ANSM Explains

    For several months now, notified bodies in the EU have ceased operations, either voluntarily or following a de-notification decision from their member state’s competent authority. As the uptick in notified body closures increases, France’s National Agency for the Safety of Medicines and Health Products (ANSM) on Monday reiterated that medical devices may only receive marketing authorization with a valid certificate and under regular device surveillance by a notified bod...
  • Regulatory NewsRegulatory News

    FDA Explains How Medical Device Companies Can Comply With UDI Marking Requirements

    New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify the process of "marking" a medical device with a Unique Device Identifier (UDI). Background Under a final rule released in September 2013, most devices marketed in the US will eventually be required to be marked with a UDI—an identifying mark used to distinguish devices from one another and make them easier to track. A UDI is composed of two parts: a device identifier that corresp...
  • Regulatory NewsRegulatory News

    FDA Decides to Delay UDI Labeling Rule for Some Orthopedic Implants

    The US Food and Drug Administration (FDA) is granting labelers of certain types of implantable medical devices a temporary reprieve from its upcoming requirements that all medical device products be marked with a unique device identifier (UDI) meant to make the devices safer. Background A UDI is, as its name implies, a system of identifying each medical device using a specific system. The system has a number of allures for regulators. "The unique device identification ...
  • Regulatory NewsRegulatory News

    Australian Government Proposes Bypassing TGA for Medical Devices with CE Marking

    Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from European Notified Bodies. The proposal, part of a new government  position paper pushing innovation and competitiveness issues, wou...
  • Regulatory NewsRegulatory News

    EU Notified Bodies Update Code of Conduct

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The European Association for Medical Devices of Notified Bodies (Team-NB) has published an updated Code of Conduct targeting more consistent and transparent CE Mark certifications from member firms. First implemented by Team-NB in early 2013, the Code of Conduct’s version 3.2 makes more explicit processes and procedures Notified B...
  • Regulatory NewsRegulatory News

    FDA Extends UDI Compliance Date for Most Contact Lenses

    Some medical device manufacturers will have an additional year to comply with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, a 2013 regulation intended to allow regulators to exercise greater oversight of the device industry. Background A UDI is, as its name implies, a system of identifying each medical device using a specific system. The system has a number of allures for regulators. "The unique device identification system will h...