top of page
Medical Device Blog
Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing
Search
EU Authorized Representative for Medical Devices
If you are a non-EU manufacturer looking to sell medical devices in the EU, you shall appointing an EU Authorized Representative
Maria
How to Write a CER as per MDR
Writing a Clinical Evaluation Report (CER) that complies with MDR 2017/745 is a complex but critical task for medical device manufacturers.
Maria
Electronic IFU
IFU electronic
Soledad
Compliance GPRS Amazon
Selling products on Amazon within the EU and UK markets requires adherence to regulatory standards GPRS Amazon
Soledad
GPSR 2023 988
The EU’s GPSR 2023/988 enforces stricter product safety, online marketplace accountability, and better recall processes for consumer protect
Soledad
New AI Act Regulation
Europe's AI Act enforces transparency, safety, and accountability in AI, ensuring responsible use and protecting consumers from risks.
Soledad
UKRP (UK Responsible Person)
A UKRP (United Kingdom Responsible Person) represents non-UK medical device manufacturers, ensuring compliance with UK regulations.
Maria
2024/1860 Template confirmation letter
The document is a formal notification from a Notified Body (NB) confirming receipt and acceptance of a medical device manufacturer.
Maria
EU Updates for Medical Devices Standards 2024/815
The European Commission recently issued a decision updating standards for Medical Devices Standards 2024/815, aiming to ensure their...
pharmaserviceinc
IMDRF 2024 Updates: Key Changes and New Procedures
IMDRF has released updates for 2024, focusing on enhancing regulatory convergence and ensuring the currency of its documentation in this doc
Maria
EUDAMED 3.8.0: New Version Deployed with Enhanced Features
The European Database on Medical Devices (EUDAMED) has launched its latest version, 3.8.0.
Soledad
Remanufacturing of Medical Devices: New FDA Guidance for Industry and Service Providers
The FDA’s new guidance on Remanufacturing of Medical Devices with significant step towards ensuring clarity and consistency.
Soledad
FDA US Agent Services with AF Pharma
AF Pharma's US Agent services provide invaluable support, ensuring compliance, smooth operations, and proper labeling for health products.
Maria
Medicines Submissions to the MHRA: A Comprehensive Guide
This blog provides a detailed walkthrough on how to make Medicines Submissions to the MHRA
Maria
Regulatory Landscape for In-House IVDs in Australia
In the dynamic world of medical diagnostics, Australian laboratories engaged in the manufacture of in-house in vitro diagnostic medical...
pharmaserviceinc
Legacy Devices (MDD CE marked devices)
Navigating the transition from MDD to MDR for Legacy Medical Devices, medical devices with CE marking under MDD. Check the information!
Maria
BioCat webinar
Explore health product trends, innovations, and success strategies in our webinar, "Opening Doors to Health Product Opportunities."
Maria
Medical device and IVD classifications
EU MDR and IVDR: Classifications & QMS are keys to compliance. Navigate changes for safer, effective medical devices in the EU
Maria
Harmonizating the QSR CFR 820 with ISO 13485:2016
Navigating the Transition Taken from Brian Newbery, Founder of Fast-Track QMS Consultants As we enter a new era in the regulatory...
Soledad
New MHRA Roadmap
MHRA's 2024 roadmap enhances UK medical device regulations, prioritizing patient safety, AI/ML guidelines, and international harmonization.
Maria
bottom of page