An extended timeframe is suggested in the position paper from the EUMDCG to allow some legacy devices that have received MDD or AIMDD certification to comply with MDR. EU MDCG 2022-18 issued ““MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the […]
EU MDCG 2022-18 : Extended Timeline for Legacy Device Compliance Read More »
An Overview: Cardiovascular Medical Device Heart valves, coronary stents, endovascular grafts, and angioplasty balloon catheters are a few examples of cardiovascular medical devices. The design and manufacturing of advanced implantable cardiovascular medical devices can be challenging and time-consuming. The degree of risk associated with the patient of these devices is higher, hence these devices are
In Brief: CDSCO Regulatory Compliance for Cardiovascular Medical Devices Read More »
The Medical device directives (MDD) is replaced by medical device regulations (MDR) in May 2021. Since then, a transitional phase has been applied to numerous medical devices. The transitional period anticipates that the medical device certified under MDD could be placed on EU market until 26May2024, if they met the legacy requirements. The situation has
EU Proposes Extensions of MDR Transition Period Read More »
What are Aesthetic Medical Devices? As per USFDA, “Aesthetic (cosmetic) devices are typically used to improve appearance. They may be regulated by FDA depending upon their intended use and whether they impact the structure or function of the body”. The availability of new and exciting aesthetic medical equipment worldwide has led to an increase in
Quick Guide to Aesthetic Medical Devices and Regulatory Compliance Read More »
Legacy Medical Devices In May 2021, the European Union Commission implemented medical device regulation (MDR) 2017/745 to make medical devices safer, more effective, and easy to trace. As per the new MDR, a manufacturer must comply with the CE certificate to sell medical devices in the European market. As a CE-marked medical device consultant, we assist
Understanding Legacy Medical Devices Read More »
Challenges In Drug-Device Combination Products: An Overview In the realm of medical innovation, Drug-Device Combination Products are witnessing a surge in demand, offering promising solutions to enhance patient care. However, alongside this growth, these products bring forth a unique set of challenges that necessitate careful consideration and strategic navigation. Let’s explore some of the key
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What are Neurological Devices? Neurological devices play a crucial role in diagnosing, preventing, and treating various neurological disorders such as Alzheimer’s disease, Parkinson’s disease, epilepsy, major depression, spinal cord injuries, and traumatic brain damage. These advanced medical devices assist in monitoring brain activity, restoring function, and improving patient outcomes. Types of Neurological Devices Neurodiagnostic Devices
Comprehensive Guide to Neurological Device Manufacturing and Regulatory Compliance Read More »
The US FDA recently revised the guidance document for identifying and responding to deficiencies in accordance with the Least Burdensome Provisions. Under the same title, one more document was issued on November 2, 2000. FDA guidance documents do not pose obligations; rather, they provide clarification regarding the applicable regulatory requirements. This FDA guidance document will
Traceability Requirements for Medical Devices in EU-MDR Medical Device Regulations came into effect in May 2021 after replacing MDD in European Union, intending to make medical devices safer, more effective, and high quality. The main aim of EU-MDR is to ensure that the medical device manufactured or imported has increased safety, efficacy, and risk-benefit ratio
Traceability Requirements for Medical Devices in EU-MDR Read More »
MDCG published guidance on EU authorized representative requirements and their role under new MedTech regulations. The MDCG guidance 2022-16 unpacks what MDR and IVDR mean for authorized representative, manufacturers and other economic operators. Authorized representatives serve as their EU contact person and they ensure compliance with regulations. MDR and IVDR enhances their responsibilities. The manufacturers
MDCG 2022-16 guidance on EU Authorized Representative Requirements Read More »
