PAGB members can access detailed regulatory intelligence on OTC medicines self care medical devices (below) and food supplements when logged in to this website (registration for PAGB members and associate members only). This information is automatically emailed on a weekly basis to PAGB members who subscribe to our Regulatory Intelligence newsletter. Contact firstname.lastname@example.org for more information about subscribing to this newsletter.
PAGB’s regulatory advice for members on Covid-19 issues is being posted to a dedicated section of our website, which is restricted to members only (log-in required). We’ve created a comprehensive blog of Covid-19-related regulatory information and policy announcements of specific relevance to the consumer healthcare industry such as MHRA guidance, international developments and Government updates to legislation, guidance and advice. This includes regulatory information on producing personal protection equipment (medical devices).
PAGB also offers a regulatory consultancy service to companies seeking early advice; for example, on the viability of bringing a product to market, understanding requirements for medical device regulation or exploring claims. Contact us about our regulatory and advertising consultancy services.
The Medical Devices Regulation (MDR) and In Vitro Medical Devices Regulation were published in the Official Journal of the European Union on 5 May 2017 and entered into force on 26 May 2017.
Now in the 3 year and 5 year respective transition periods these regulations aim to better protect public health and patient safety by increasing the pre- and post-market scrutiny of medical devices on the European market.
During these transition periods, products can be placed on the market if they comply with either these new regulations or those they are intended to replace.
PAGB’s work on the MDR as it applies to products in the scope of our membership is coordinated through the Medical Devices Regulatory Group.
For medical device products to be within scope of PAGB membership they must;
For more information on which devices fall into scope of PAGB membership please contact email@example.com