The EU Parliament has the power to adapt enforcement of CE regulations in the face of this crisis.
l've poked my head into a couple of European OS ventilator projects, who began to worry about compliance/ legal stuff. The EU's FDA equivalent (called the EMA) told me to talk to individual member state health ministries. l contacted the health ministries of Italy, Spain and France to ask if they have a EUA equivalent. Italy says they want to expedite but need more information, they have no enforcement policy. France said they will expedite clinical trials. Spain returned a document (https://drive.google.com/file/d/1xtO3Km3Gyp8meZ0iwAtykxVlV7mPkEfa/view?usp=sharing) that listed ISO regulatory demands that seem quite rigid.
But the biggest hurdle is third party testing/ certification companies are offline in places like Italy and Spain. This sucks. A design cannot get to the patient if it cannot get through the red tape.
Pardon my forwardness: sign my petition?
Petition is hosted here, a copy was also submitted to the EU Parliament: https://secure.avaaz.org/en/community_petitions/european_union_ema_european_medicines_angency_must_issue_emergency_use_authorization_for_coronavirus_med_tech/details/
The EU Parliament has the power to adapt enforcement of CE regulations in the face of this crisis.
l've poked my head into a couple of European OS ventilator projects, who began to worry about compliance/ legal stuff. The EU's FDA equivalent (called the EMA) told me to talk to individual member state health ministries. l contacted the health ministries of Italy, Spain and France to ask if they have a EUA equivalent. Italy says they want to expedite but need more information, they have no enforcement policy. France said they will expedite clinical trials. Spain returned a document (https://drive.google.com/file/d/1xtO3Km3Gyp8meZ0iwAtykxVlV7mPkEfa/view?usp=sharing) that listed ISO regulatory demands that seem quite rigid. But the biggest hurdle is third party testing/ certification companies are offline in places like Italy and Spain. This sucks. A design cannot get to the patient if it cannot get through the red tape.
Please sign the petition.