The guidance document defines cybersecurity as, “the body of technologies, processes, practices, responses and mitigation measures designed to protect a medical device against unauthorized access, modification, misuse, or denial-or-use, and against the unauthorized use of information stored, accessed, or transferred to or from a medical device.”
On June 6th, 2019 the European Union released a document, with a note from the Irish and German Delegations on the implementation of Regulation (EU) 2017/745 on medical devices. The document addresses the increased number of discussions regarding the challenges and concerns facing stakeholders (manufacturers, notified bodies, authorized representatives, distributors, competent authorities, European Commission) in the medical device sector to implement the new Regulations in a timely and effective manner.
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 International Medical Device Regulators Forum (IMDRF) held the fifteenth meeting of the Management Committee (MC) in Moscow, Russia on March 18th -21st, 2019. The MC consisted of regulatory leaders from around the world such as: Australia, Brazil, Canada, China, the European Union (EU), Japan, Russia, Singapore, South Korea, and the USA.
On March 13th, 2019 the Council of the European Union released two corrigenda documents, pertaining to the Regulation (EU) 2017/745 on Medical Devices and the (EU) 2017/746 on In Vitro Diagnostics Medical Devices. In an effort to rectify mistakes and discrepancies within the new European Regulatory framework, Member States were allowed to send comments and suggestions up until March 20th of this year. Then, on May 5th,2019 the official documents for the (EU) MDR 2017/745 and IVDR 2017/746 corrigenda were released by the Official Journal of the European Union.
The European Medicines Agency (EMA) plans on publishing a series of guidance documents to assist applicants in the medical device industry in preparation of the obligations delivered by the new Regulation (EU) 2017/745 on medical devices. This guidance document falls within the scope of EMA’s activities and should be read in alignment with the new Regulations (EU) 2017/745 on medical devices and (EU) 2017/746 on In Vitro Diagnostic medical devices.
A recent survey was conducted by Team-NB to determine how notified bodies were approaching the application process for designation under the new EU IVDR 2017/746. The survey report was closed on January 11th, 2019 and reveals that a total of 35 notified bodies responded, twenty of those were members of Team NB and fifteen were not (non-members NB).
Since its publication, many articles have been published regarding the potential implications of the new European Medical Device Regulation (MDR) on the CE-marked medical devices within the European Union. However this change of regulation goes further than only the European Union (EU) and affects also other European countries (Not European Union Member-State).
A survey was recently administered by ISO TC210 WG1 to obtain critical information to evaluate the experiences of key stakeholders such as, medical device manufacturers, subcontractors, suppliers, European Authorized Representatives, specialized consulting firms etc., during the ISO 13485:2016 transition. ISO TC210 is a taskforce focused on the quality and performance of medical devices. They have numerous deliverables that consist of, standards, risk management, guidance documents, usability, and quality management, to name a few.