Introductory Remarks Continuing our examination of the MDR/IVDR transition period, we delve into the transition period’s subtler points. In this section, we examine the conditions manufacturers must meet in order to benefit from the extended transition, as well as the evidence required to support this procedure. In addition, we explicate the nuances of transitioning surveillance […]
New MDR includes the following products as devices for the first time: Contact lenses or other items intended to be introduced into or onto the eye. e.g. coloured contact lenses without correction of vision; Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying […]
The Regulation (EU) 2017/745 relating to medical devices, which amends Directive 2001/83 / EC (Community code relating to medicinal products for human use), Regulation (EC) n. 178/2002 (food safety) and regulation (EC) n. 1223/2009 (cosmetics) and repealing directives 90/385 / EEC (active implantable medical devices) and 93/42 / EEC (medical devices), entered into force on […]
ISO 10993-1: 2018 is the 5th edition of the biocompatibility standard for evaluation of medical devices. The new version replaces the 2009 version of the standard. Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. However, since 2009, the emphasis on a risk management […]
UDI is one small part of a complete revamp of European Medical Device (MDR) and IVD (IVDR) regulations. European UDI system implements IMDRF UDI guidance throughout Europe — Article 27 of MDR — Article 24 of IVDR UDI in MDR Chapter III – Identification and Traceability of devices Article 27 -UDI system Article 28 -UDI […]
MEDDEV 2.7.1 Rev 4 – Demystifying the new requirements MEDDEV 2.7/1 is a guiding document for clinical evaluation of medical devices and it is titled as “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC”. MEDDEV 2.7/1 revision 04 (guideline for clinical evaluations) is available for guidance since 1st July 2016. […]