We would like to inform our clients that the Maltese Competent Authority, the Malta Medicines Authority (MMA), has introduced a new dedicated email address for vigilance communications. The updated email address is: mdvigilance.medicinesauthority@gov.mt Please be aware that the official Vigilance contact points list published by the European Commission (available at this link) has not yet … Read more
The MDCG have published a template for the Summary of Safety and Performance (SSP) as required by the EU IVD Regulation 2017/746 (IVDR) for Class C and Class D devices. The format of the SSP will depend on whether the device used is intended for self-testing. If it is not, then there shall be another … Read more
As many of you will already know, the requirements regarding Post Market Clinical follow up and Post Market Surveillance have increased dramatically in recent years. This is not only a result of the changes made within MEDDEV 2.7/1 Rev 4 June 2016 but also Clause 8.2.1 and 8.2.3 of ISO 13485: 2016, and in addition … Read more
The Post-Market Clinical Follow-up (PMCF) is a post market activity which should form part of a manufacturer’s PMS plan. It consists of proactively collecting and evaluating clinical data related to the use of a CE marked device already on the market. The aim of the PMCF is to confirm the safety and performance of the … Read more
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