13. Information supplied by the manufacturer. 13.1. Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential users. This information comprises the details on the label and the data in the instructions for use.

2022年6月17日 · Learn the key differences between the new Medical Device Regulation (MDR) and the Medical Devices Direction (MDD), including items related to safety, performance, clinical data, CE marking, incident reporting, and much more.

MDD MAXDIGITALDATA 13TB 7200RPM 256MB Cache SAS 12.0Gb/s 3.5inch Internal Enterprise Hard Drive (MDD13TSAS25672E) - [ NOT a SATA HDD ] Highest capacity. 13TB means you get the highest storage capacity available in the 3.5-inch Server class.

The MDD sets out 13 essential requirements (ERs) covering: General requirements, principally regarding risk; The MDR sets out 23 GSPRs covering: General requirements, principally regarding risk; Products without a medical purpose; Chemical, physical and biological properties; Chemical, physical and biological properties; Where there are 13 ERs ...

2019年7月8日 · Article 13. General obligations of importers. 1. Importers shall place on the Union market only devices that are in conformity with this Regulation. 2. In order to place a device on the market, importers shall verify that:

Risk management is a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic update. It requires a manufacturer to: .

2020年11月24日 · See how EU MDD and MDR compare, what is the transition period, and what are the main similarities and differences you should be aware of.

Classification rules - MDD • The current Directive 93/42/EEC classification rules state under Rule 18 that: “By derogation from other rules, blood bags are in Class IIb.” • Rule 13 MDD states: All devices incorporating, as an integral part , a substance which, if used separately, can be considered to be a medicinal

2019年8月14日 · Procedure for custom-made devices. 1. For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following information:

13.1. Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer. This information comprises the details on …