One step closer to new rules on medical devices

On 7 March 2017, the Council of the European Union adopted the new EU rules on medical devices.

As mentioned in our newsletter of 2 June 2016, the European Parliament and the Council of the European Union came to an agreement back then about the regulation drafts for the new rules on medical devices and in vitro diagnostic medical devices. However, the actual adoption of the new rules required a formal approval.

Thus, the Council of the European Union's adoption is just one step on the road as the European Parliament also has to adopt the rules. This is expected to happen in April 2017. Subsequently, the implementation time will be three years in relation to medical devices and five years in relation to in vitro diagnostic medical devices. However, the regulations adopted by the Council of the European Union have already been made public. Links are provided below.

The new rules aim to improve the safety of medical devices by strengthening oversight and control both before and after the launch of medical devices.

We will keep track of the development, and before the final implementation we will focus on some of the new provisions, as well as the challenges and possibilities for companies and the effect of the new rules.

Read the press release of the Council of the European Union here

Read the Regulation on medical devices adopted by the Council of the European Union here

Read the Regulation on in vitro diagnostic medical devices adopted by the Council of the European Union here

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