Medical Device Labeling Requirements Europe

Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr.

Medical device labeling requirements europe.

The name and trade name of the device. China medical device labeling requirements language. Medical devices in the eu have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. The medical devices and the in vitro diagnostic devices regulations have introduced new responsibilities for the european medicines agency ema and national competent authorities in the assessment of certain categories of medical device.

General device labeling 21 cfr part 801 use of symbols. The mdr brings many challenges for medical device manufacturers. Medical device labeling is considered as important as classifying a product or creating an insulation diagram. Some of the key information that manufacturers must include on their medical devices include.

The unbearable insensitivity of risk management language. Sterile non sterile. Iso 13485 2016 medical devices quality management systems requirements for regulatory purposes iso 15223 1 2016 medical devices symbols to be used with medical device labels labelling and information to be supplied part 1. All information for safe installation use storage servicing and maintenance of the device must be provided to the user.

The mdr will become enforceable in 2020 and introduces new rules relating to labeling requirements for medical devices. China medical device regulations. Manufacture date if no expiration date indication that the device is a medical device all labels must include a standardized symbol to indicate that the package being shipped into the eu contains a medical device. Section 23 of annex i of the mdr defines the general safety and performance requirements spr for labels and instructions for use.

On may 5 2017 the european commission released the new europe eu medical device regulations mdr in an effort to create a more unified and transparent system for medical devices. Explicit requirements for sterile barrier labeling identification the sterile barrier declaration of the sterile condition e g. General requirements iso 14971 2012 medical devices application of risk management to medical devices. For medical devices ce marking will continue to be used and recognised for both the uk and eu markets and uk based industry will not require an authorised representative established in the eu.

Other medical device regulations world wide. European databank on medical devices currently exists and use has been mandatory for use since 2011 major overhaul for mdr.