Home » New European Medical Device Directives Expected This Fall
New European Medical Device Directives Expected This Fall
The new European medical device directives are expected to be adopted this fall, implemented by the end of 2008 and enforced by 2010, Cristiana Spontoni, European partner with Squire, Sanders & Dempsey, said at the recent FDAnews Medical Device Quality Congress.
The European Parliament recently approved the amendments to the directives. The amendments narrow the definition of a single-use device and obligate the European Commission to further study the practice of reprocessing single-use devices, according to Spontoni.
Although industry generally supports the new rules, Spontoni noted, “The devil is in the details,” and recommended manufacturers pay attention as the rules are adopted and implemented.
During the conference, Spontoni discussed some of the key changes under the amendments, including new requirements for notifying bodies. Under the European system, notifying bodies are designated by member state regulators and evaluate a product’s compliance with requirements for CE marking. All medical devices in Europe must have a CE mark to be commercialized.Upcoming Events
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