Medical Devices Regulation: Regulation 2020/561 has been published in the Official Journal of the European Union postponing the date of application of MDR by one year to 26 May 2021
9
Apr 20
Medical Devices Regulation: EU Commission proposes a one year postponement of the application date
On 3 April 2020, to prioritize the fight against the Covid-19 pandemic crisis, the European Commission adopted a proposal to (i) postpone the date of application of Regulation (EU) 2017/745 on medical devices (“MD Regulation”) (scheduled for 26 May 2020) by one year and (ii) deviate from the normal conformity assessment procedures of medical devices in cases of need and emergency.
Medical Devices Regulation: European Commission adopted a proposal to postpone the date of application of the MDR by one year, until 26 May 2021
11
Feb 20
Medicine and medical device e-commerce: regulatory restrictions and opportunities
More and more healthcare and pharmaceutical companies are entering the world of e-commerce.
5
Feb 20
Class I medical device manufacturers may benefit from the transitional period under the MDR
On December 17, a corrigendum to Medical Device Regulation (MDR) 745/2017 was approved by the European Parliament that allows certain devices classified in Class I under Directive 93/42/EEC to benefit from the transitional period provided by the MDR.
5
Feb 20
Who can request authorization to advertise medicines? Answers from the AGCM
The Italian Competition Authority (hereinafter the “AGCM“) recently expressed an opinion and addressed a recommendation to the Ministry of Health (the “Ministry”) regarding the parties entitled to request authorization to advertise medicinal products to the public (resolution No. AS1628 of December 9, 2019
