EVERBIZ News Center: company news, global medical device regulatory updates, and registration and compliance insights.
EU Safety Requirements for General Consumer Products
Regulation (EU) 2023/988 on general product safety (GPSR) was adopted on 10 May 2023, entered into force on 30 May 2023 and has applied since 13 December 2024. The Regulation applies to: (1) products placed or made available on the market, provided there are no specific provisions in Union law with the same objective governing…
EU Decision No 768/2008/EC (Common Framework for the Marketing of Products) – Download
This resource is the official English version of EU Decision No 768/2008/EC, one of the core documents of the EU’s New Legislative Framework (NLF). About this document The Decision provides a common framework for EU harmonisation legislation on products, setting out the conformity assessment modules (Modules A–H), the principles for using the CE marking, and…
Core Parts of 21 CFR Relevant to the FDA
The FDA (US Food and Drug Administration) regulatory framework for medical devices consists of multiple parts of 21 CFR (Code of Federal Regulations) Parts 800–898 (Subchapter H). These regulations cover the entire life cycle from device development and manufacturing to post-market surveillance. The chart below gives an overview of the core Parts of medical device…
FDA Medical Device Recalls Explained
A recall is a method of removing or correcting products that violate laws administered by the US Food and Drug Administration (FDA). It is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect public health and well-being from products that present a risk of injury, gross deception or…
FDA Warning Letters to Medical Device Companies Explained
The core value of FDA warning letters is that they clearly show “which practices do not comply with regulations”. The violations they list (such as quality system deficiencies, failed design controls and labelling errors) are effectively “cautionary examples” for companies’ self-inspection and correction. Specifically, they help in the following ways: (1) Companies can use real…
Interpreting the FDA Guidance on Evaluating Sex-Specific Data in Medical Device Clinical Studies
The US Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER), issued a guidance document on 31 March 2025. Download the guidance at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-sex-specific-data-medical-device-clinical-studies-guidance-industry-and-food-and-drug The guidance provides recommendations on the study and evaluation of sex-specific data in medical device clinical studies The…
EU Biocidal Product Authorisation and Treated Article Registration
The EU Biocidal Products Regulation (Regulation (EU) 528/2012), abbreviated EU BPR, has applied since 1 September 2013. It requires all biocidal products to be authorised before being placed on the market, and the active substances in them must already have been approved by the European Commission. Download Regulation (EU) 528/2012 at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32012R0528 1. Basic concepts…
Finding Core Information on Predicate Devices on the FDA Website
Core information on predicate medical devices can be obtained systematically from the FDA website. Here is a detailed guide: 1. Overview in one chart 2. Using product classification and guidance documents to find information Clarify the product’s regulatory requirements: in the Product Classification database, look up the regulation number for the product code (e.g. 21…
FDA Medical Device Product Codes
The FDA medical device product code consists of three letters and is an important identifier of device type and product classification. It not only helps determine a device’s risk class (e.g. Class I low risk, Class II moderate risk, Class III high risk) but also clarifies the regulatory requirements for each risk class, making it…
How to Look Up US 21 CFR Regulations
21 CFR (Title 21 of the Code of Federal Regulations) is the core body of regulations of the US Food and Drug Administration (FDA) covering food, drugs, medical devices, cosmetics and other areas. Its structure is large and complex: 21 CFR is divided into three Chapters, each containing multiple Subchapters and Parts. In one chart:…
Introduction to EU MDR Class IIa Products
The main EU legislation on medical device classification is the EU Medical Device Regulation (Regulation (EU) 2017/745, MDR), and the main guidance document is MDCG 2021-24, Guidance on classification of medical devices. The Regulation divides medical devices into Classes I, IIa, IIb and III. Our earlier WeChat articles covered EU Class I products in detail.…
Introduction to EU MDR Class IIb Products
The main EU legislation on medical device classification is the EU Medical Device Regulation (Regulation (EU) 2017/745, MDR), and the main guidance document is MDCG 2021-24, Guidance on classification of medical devices. The Regulation divides medical devices into Classes I, IIa, IIb and III. Our earlier WeChat articles covered EU Class I and Class IIa…