On 15 June 2016, the Council's Permanent Representatives Committee endorsed the agreement reached with the European Parliament on 25 May on the new medical devices regulations. The Commission stated that it can also support the agreement reached between the two co-legislators.
If the agreement is confirmed by the Parliament's ENVI committee the Council will approve the agreement at ministers' level. This is planned for September, once the draft regulations have been translated into all official languages. Following their legal-linguistic review the two draft regulations will be adopted by the Council and the Parliament, probably at the end of the year. The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.
"The new EU rules have a twofold aim: making sure that medical devices and in vitro diagnostic medical devices are safe, while allowing patients to benefit from innovative health care solutions in a timely manner. They also contribute to promote growth and create jobs in the EU by offering manufacturers the right legal framework to produce the devices that patients ask for", said Edith Schippers, Minister of Health of the Netherlands and President of the Council.
Medical devices and in vitro diagnostic medical devices cover a wide range of products, from sticking plasters to hip replacements, and from pregnancy tests to HIV tests.
The new EU regulations:
Authorities are trying to understand the motives of the man who killed 49 people and wounded 53 more on Saturday evening in Orlando, Florida. Four men remain in critical conditions and 28 are still in hospital from the deadliest mass shooting attack in US history.
The motives of the 29-year old shooter Omar Mir Seddique Mateen are not straightforward.
President Barack Obama said on Tuesday that Mateen was “an angry, disturbed, unstable young man who became radicalized.” However, investigators have said that there is no evidence Mateen had been in contact with groups such as IS.
Moreover, it appears Saturday evening was not the first time Mateen was visiting Pulse. He had been several times before and witnesses suggest he was flirting with other men. Sources speak of other nightclubs as well. And there are more witnesses yet who say the man was visiting gay chat-rooms online. Investigators also place him in a number of venues associated with Gay Days 2016, a city-wide celebration, which may suggest surveillance.
The question now being asked was whether this was a planning routine or something else.
Matten’s former colleague Dan Gilroy told CNN that he constantly made homophobic, sexist and racist remarks. While his father said on Tuesday he did not think his son was gay. His ex-wife Sitora Yusufiy, with whom he had a 3-year old son, says she does not know whether Mateen was gay, but would not be surprised if he wa since he was “in such deep conflict within himself.”
Mateen has been twice investigated in 2014 when he suggested he have links to terrorist at work. Mateen has worked as a security officer.
His second Noor Zahi Salman told the FBI she was with him when he bought ammunition and that she once drove him to Pulse. Authorities are whether to prosecute Noor as it is believed she may have had prior knowledge of the attack.
Born in New York, Mateen had a degree in criminal justice technology.
(BBC, CNN, NBC)
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