Noticias y novedades
Important Update on Medical Device Regulation in the UK
The UK government has outlined a roadmap for a new regulatory framework that prioritizes patient safety and ensures access to safe and innovative medical devices. Here are the key dates to keep in mind: 📌 2024 Implementation of priority [...]
Master UDI-DI for Contact Lenses: What Manufacturers Need to Know
Learn about the new Master UDI-DI for contact lenses: requirements, Eudamed registration, and mandatory compliance timeline. The Master UDI-DI system is an essential development for the contact lens industry, providing a streamlined approach to traceability and ensuring compliance with [...]
Streamline Your Compliance Process with the New CAPA Template – MDCG 2024-12
The MDCG 2024-12 template is a vital tool for managing Corrective and Preventive Actions (CAPA) under MDR and IVDR. By providing a structured framework, this template simplifies the process of addressing non-conformities (NCs) and ensures organizations remain compliant with [...]
Eudamed modules: Key steps for medical device compliance
What is Eudamed and why is it important? Eudamed is the European database for medical devices, designed to improve transparency, traceability, and regulatory oversight across the EU market. By centralizing data related to medical device registration, post-market surveillance, and clinical [...]
Post-Market Surveillance (PMS): A Key Pillar for Compliance and Innovation in the Medical Device Industry
In the rapidly evolving field of medical devices, compliance with Post-Market Surveillance (PMS) requirements has become a cornerstone of safety, innovation, and market competitiveness. However, a recent report by the Health and Youth Care Inspectorate (IGJ) paints a concerning picture: [...]
Is the FSC valid indefinitely, or does it have an expiration date?
If you’re a medical device manufacturer, understanding the validity of your FSC (Free Sales Certificate) is crucial for maintaining market access and ensuring regulatory compliance. The FSC doesn't have a specific expiration date. Instead, its validity depends on the regulations [...]
How to Obtain CDSCO Approval for Medical Devices
Obtaining CDSCO (Central Drugs Standard Control Organization) approval in India is a crucial step for entering this growing market. The process starts with submitting a detailed application that includes the Intended Use of your product and provides evidence of safety [...]
When Should You Involve a CRO in Medical Device Development?
The optimal time to engage a Contract Research Organization (CRO) in your medical device’s development is as early as possible, ideally during the initial planning phase of your clinical study. Involving a CRO from the outset ensures a study [...]
New Revision of European Medical Device Regulations: Towards Greater Transparency and Safer Access for All
In response to current challenges regarding the accessibility and safety of medical devices, the European Parliament approved a landmark resolution on October 23, 2024, to revise the regulatory framework for these products across the European Union. This urgent update [...]
