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Medical technology

Medical technology is about products, technologies and applications used in the diagnosis, treatment and support of diseases and disorders. Innovative technologies are rapidly being developed to improve care. Increasingly, medical technology determines the quality of care.

Field safety notices

Recent field safety notices (FSN's) from medical device manufacturers:

Field Safety Notice: Gabmed - gabControl D-Dimer rapid test


Due to weakly visible test lines in the said batches, it came to an increased amount of false-negative results.

Field Safety Notice: Oscor Europe - Delivery Sheath Adelante® Breezeway® 8F & 10F


Oscor Inc. has been made aware of a complaint where a fragment of the sheath inner liner came off during the insertion of the dilator during the preparation of the...

More field safey notices


Recent developments on the field of supervision of medical technology:

Manufacturers of silicone breast implants must improve their technical files 
Laboratory investigation on the breast implants did not identify anomalies that may compromise health of patients. However, the technical files of the implants, which...

Investigation into possible problems with hypodermic needles reveals negligible risk
Hypodermic needles produced by Terumo and other manufacturers pose negligible health risks. There is no reason not to use these needles. Nevertheless, Terumo should...

More news     



Requirements for labelling, instructions and language

Requirements for labelling, instructions and language

Each medical device must be accompanied by a clear label, instructions for use and, where applicable, a display.

Conducting clinical research with a medical device?

Conducting clinical research with a medical device?

Read more about how to notify clinical research and report Serious Adverse Events to the Inspectorate.