The European Union has constructed an excel document detailing essential information regarding the MDR/IVDR implementation rolling plan. The document is organized into two different sections: implementing acts and other actions/initiatives. This document is intended to coexist with the “MDR/IVDR roadmap,” which was created by the Competent Authorities for Medical Devices project (CAMD) In cooperation with the EU Commission which involves a much more detailed synopsis of all the initiatives and guidance documents expected to be undertaken during the period of transition by the Commission and the National Competent Authorities.
The columns in the document are comprised of five main headings: subject, legal basis, description, expected timelines and state-of-play/next steps. The first section, implementing regulations/acts, starts with a focus on the scope of Notified Bodies designation for the MDR/IVDR. Further, it discusses the implementing acts for other topics such as: reprocessing of single-use medical devices, EUDAMED, Unique Device Identification (UDI) System: designation of issuing entities, reprocessing of single-use medical devices, etc. With each implementing act subject the appropriate Article for the relevant Regulatory document and timeline is referenced.
The second section, actions/initiatives (other than implementing regulations/acts), also focuses on Notified Bodies designation as a starting point, similar to the first section of the document. However, it has a much deeper focus on EUDAMED with respect to, drawing up functional specifications, audit of functional specification, going live, and setting up of a help desk. It also focuses on other subjects regarding the MDCG and EU medical device nomenclature.
The last update for this document was on April 2019. This document will be subject to quarterly reviews in order to maintain the most up to date information for authorities and stakeholders.