Category: Clinical & Consulting

Navigate the complexities of SSCP development with expert insights on ensuring compliance, readability, and alignment with EU MDR Article 32 for medical devices.

Since the implementation of the Medical Device Regulation (2017/745) (MDR) in Europe, manufacturers must proactively monitor the safety and performance of their medical devices throughout their entire lifecycle. Post-Market Clinical Follow-Up (PMCF) surveys have become widely accepted as an essential component of PMCF data collection. These surveys are a valuable tool for gathering real-world data … Continued

The MDR introduces more stringent requirements for medical device manufacturers, emphasizing patient safety and a clinical evidence-based approach to the confirmation of the benefit-risk determination for each device. Under the MDD, the term PMCF was associated with formal post-market studies and only considered necessary for a few high-risk or novel devices. Under the MDR, PMCF is an integral part of the post-market surveillance (PMS) process applicable for all devices. Another important change with the MDR is that PMCF is defined as a continuous process which updates the clinical evaluation. To place a product on the market in Europe under the MDR is therefore a commitment to continue to gather information, including clinical data, for the lifetime of the device. Further insights are available in the white paper on device lifetime co-authored by NAMSA and BSI.

MDCG 2024-10, published in June 2024, addresses the difficulties in generating clinical data for devices specifically intended for use in rare diseases/conditions or specific indications for rare cohorts of patients with non-rare diseases/conditions. The MDCG introduces the phrase orphan devices to identify those devices that have precise indications used in a small patient population where gathering sufficient pre-market clinical data can be challenging, particularly given the increased requirements of the Medical Device Regulation (MDR).

Learn about EMDN updates in the new MDCG 2024-2 guidance and its impact on medical device manufacturers.

This blog covers the EU Commission’s newly published MDCG Guidance documents relating to medical device and in vitro diagnostic medical device vigilance.

This blog covers the latest updates to the European Commission’s harmonized classification and labeling of chemicals, including significant changes to the CLP Regulation that could impact medical devices.

This blog delves into the changes in the MDCG 2021-6 Revision 1 and NAMSA Experts’ take on what the changes mean for manufacturers.

In an important step forward for EU manufacturers of devices without a medical purpose, the final version of the ‘Implementing Regulation’ containing the common specifications related to the Medical Device Regulation (MDR) have been adopted.

Medical device manufacturers must first ensure that their QMS conforms to the specified requirements and is effectively implemented and maintained. On the path towards ISO 13485 certification, manufacturers should undergo an internal audit and then an external certification audit. This article supports manufacturers in understanding the auditing process toward ISO 13485 certification.

Today, the EU medical device industry reached a major milestone with the arrival of the extended application deadline for the European Union Medical Device Regulation (EU MDR 2017/745).

With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.