Still confused about the regulatory changes affecting medical devices and in vitro devices? The EU Commission has published a useful factsheet, which you can find here.
Through the factsheet, the Commission warns health institutions and healthcare professionals that the upcoming changes may have consequences on the availability of medical devices because manufacturers may decide to stop their production or because products may not get their certificates on time.
Some notified bodies have also decided to drop off and only two notified bodies have been MDR designated so far, so this will create additional bottlenecks. A short grace period until 2025 is granted, but it does not apply to class I devices.
The path to an enhanced regulatory framework will be complicated and manufacturers, healthcare institutions and healthcare professionals need to know what to expect.
The rules on continuing medical education (“CME”) have changed since a new agreement between the Italian government, the Italian Regions and the autonomous provinces of Trento and Bolzano has come into force on February 2, 2018. You may find the new agreement here or here (only in Italian, sorry).
The agreement is an “upgraded version” of the previous principles, which remain largely unchanged, but are now better defined, stricter and hopefully more effective.
- THE RIGHT TO CME. Health care professionals (“HCPs”) have the right to obtaining CME and regulators will need to remove impediments in order to allow the exercise of such right.
- ACCREDITATION OF PROVIDERS. As before, providers of CME need to be accredited, but accreditation will be subject to stricter rules, which particularly focus on avoiding any conflicts of interest. Providers will also need to adopt an internal regulation setting forth how to prevent and exclude (even potential) conflicts of interest.
- SPONSORSHIP OF EVENTS. Sponsorship of CME events will be possible by private companies, provided that the principles of transparency, objectivity, impartiality and independence are complied with. No advertisement of medicinal products or medical devices can be carried out during the CME event, but only before, after and outside the event. No direct payments or reimbursements are allowed to speakers or moderators of the CME events.
- NO ACCESS TO PERSONAL DATA OF HCPs. On the data protection front, note that sponsors of CME cannot have access to lists and addresses of participants, speakers or moderators.
- SPONSORSHIP OF HCPs. Lastly, HCPs may be sponsored by commercial firms operating in the health industry, but cannot fulfil more than one third of their CME requirement through such sponsorship. This is bound to change how CME has been handled before, forcing HCPs to bear the cost of at least two thirds of their CME requirements.
Have a great weekend!