Last week’s round -up;
27 September – 01 October 2021
CEPs: Revised terms of reference and rules of procedure
A revised version of the terms of reference and rules of procedure for certification of suitability has been adopted by the Certification Steering Committee and is available on the EDQM website. This revision clarifies the title and certain working procedures and takes into account the organisational changes in the EDQM Certification of Substances Department.
New EDQM IT tool for the management of CEP activities
As of October 2021, the CEP Department (DCEP) of the EDQM will use a new IT application for the management of its activities. The implementation of this tool will entail certain changes in the way the Directorate communicates with applicants for CEPs and CEP holders: Communication with companies regarding CEP applications will occur via e-mails or automatic notifications which will be sent instead of letters in an increasing number of situations, such as reminders and acknowledgements of receipt of responses to deficiency letters and requests for revisions. Therefore, applicants are strongly advised to provide the DCEP with the name and valid e-mail address of a suitable contact person and to inform the department whenever any changes occur. Applicants will now receive documents via the “EDQM DCEP Sharing tool”, which allows documents to be shared securely. Documents will be available for download for 60 days and will be deleted from the tool afterwards. The EDQM CERTIFICATION Database will display in real time the reasons why any CEPs are no longer valid (e.g. in case of suspension, withdrawal or expiry).
Medical Device Reforms – TGA to strengthen the regulation of medical devices in Australia
‘Early 2019 and mid 2021, the TGA undertook public consultations on proposals to reclassify a number of categories of medical devices so that they align, wherever possible, with the changes being introduced in European Union (EU) medical devices framework.From 25 November 2021, medical devices which are intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices. Transitional arrangements are in place for medical devices registered with ARTG prior to 25 November 2021, to allow for continued supply your device whilst undergoing the transition to Class III medical device.’