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MedTech provides update on EU medical devices regulations
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MedTech Europe, an alliance of Eucomed and the European Diagnostic Manufacturers Association, released an updated position on two proposed European Union regulations for medical devices and in vitro diagnostics. The alliance released its position ahead of an upcoming trilogue to consider the two regulations.
The alliance urged the European Union (EU) to consider the proposed measures as consistent and ones that meet the objectives of the regulations, which are to increase patient safety and increase innovation in European medical technology.
According to the European Diagnostic Manufacturers Association (EDMA), several factors for the in vitro diagnostics (IVDs) regulation must be considered, including adapting clinical evidence requirements to the specific nature of the IVDs to avoid unnecessary burden to the industry.
EDMA representatives noted a new classification system must adhere to international standards set by the Global Harmonization Task Force and labeling requirements should just focus on relevant information users need to know.
Eucomed also addressed several areas of concern for the medical devices sector to ensure the EU provided improved levels of patient safety across Europe.
Reference: www.medtecheurope.org