EU MDR

Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements. This, of course, is a significant concern for medical device manufacturers in the EU. [...]

There are only a handful of explicit things that you MUST do for Post Market Surveillance under the European Medical Device Regulation (MDR 2017/745); however, there are many things you SHOULD be doing to continuously [...]

Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the safety and effectiveness of your product is the first step of proving its quality attributes. [...]

The MEDDEV 2.7.1 is the most important technical guidance document for literature search under the MDR in the medical device regulatory industry. Since the MDCG documents do not currently offer any concrete guidance on [...]

The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout the quality system, they are not limited to the distributed product alone. Preventive [...]

While larger manufacturers, global players, and multinational companies most likely won’t have problems complying with the European MDR due to having both the financial and human resources to comply in time, smaller and medium-sized [...]

Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern medical devices are manufactured with integrated software and software in general has become [...]

In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of medical devices in a "clinical evaluation"’. With the breast implant scandal in [...]

The MDR forces manufacturers to set up processes for continuous literature reviews and reevaluation of the available clinical data. In May 2021, the European Medical Device Directive (93/42/EEC) was replaced with the Medical Device [...]

Breaking Down EU MDR Implementation for Class 1 Medical Devices   Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class I [...]

All MedTech companies face increased post-market surveillance (PMS) requirements under the EU MDR and IVDR. A PMS plan will incorporate a Post-Market Clinical Follow-up (PMCF) plan or justification for why it is unnecessary.   [...]

Introduction to Software as a Medical Device in MDR The MDCG's Guidance document defines the criteria for software qualification falling within the scope of the EU MDR and IVDR.   This article seeks to [...]