The EU MDR and IVDR will usher in increased post market surveillance (PMS) requirements for all MedTech companies, mandating a PMS plan that includes a Post-Market Clinical Follow-up (PMCF) plan or justification for why it is not required. Higher-risk devices and IVDs will require a Periodic Safety Update Report (PSUR), while for lower-class devices, a [...]
Introduction to Software as a Medical Device in MDR The MDCG’s Guidance document defines the criteria for the qualification of software falling within the scope of the EU MDR and IVDR, and seeks to elucidate which software will be considered a medical device (qualification) and its subsequent risk classification (classification). Although it is not legally binding, [...]
How to Hire an EU MDR Literature Search (or CER) Writer and What to Look For With the upcoming transition to the EU MDR ( Medical Device Regulation (MDR) 2017/745) in May 2021, medical device manufacturers are facing constant monitoring and life-cycle management of their clinical data. In the European Union, the Clinical Evaluation Report (CER) is critical [...]
With ongoing negotiations over a trade deal between the UK and the EU and less than 30 days until the end of the Brexit transition period, the UK Government continues to flesh out guidance on how it will regulate medical devices. It is likely, given the current circumstances, that the Brexit transition period will [...]
In accordance with the guidance posted by the UK Medicines and Healthcare products Regulatory Agency (MHRA), from 1 January 2021 the MHRA will undertake the responsibilities for the UK medical devices market, previously under the EU, leading to a number of changes with regards to how medical devices are placed on the market in [...]
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its conformity assessment procedures. Through the CEAR, the MDCG aims to standardize the documentation of the NBs’ assessment of manufacturers’ clinical [...]
Medical device regulations in China are often likened to the European Union (EU)’s MDR, with a vital prerequisite of Clinical Evaluation Reports (CERs), as required by China’s National Medical Products Administration NMPA (formerly CFDA). Although both the aforementioned regulatory frameworks permit the use of equivalent devices as a basis for clinical data for a [...]
The classification of medical device software (MDSWs) has very significant consequences for a manufacturer as the product life cycle reporting is strongly dependent on the risk class. Consequently, proposed changes in classification are a leading cause of concern owing to up-classification. For manufacturers, a cautionary approach to Rule 11 may lead to situations where [...]
PMCF Guidance An important constituent of Post Market Surveillance (PMS), Post Market Clinical Follow Up (PMCF) is a continuous lifecycle process, wherein the device’s clinical evaluation is constantly updated, confirming its safety and clinical performance throughout its expected lifetime. Since the requirements are said to increase under the MDR, this would necessitate prudent, thorough [...]
IVDR Part II - Your Technical Documentation and Performance Evaluation In the previous article we had discussed some of the major changes to be considered in the EU IVDR; namely increased regulatory oversight, expanded clinical evidence requirements, greater requirements for IVD manufacturers and intensified supervision of Notified Bodies. This article drills further down into [...]
