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 email@example.com 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.
In order to place a medical device on the market manufacturers must ensure their devices meet certain essential performance and safety requirements, taking account of the intended purpose. Medical devices are classified according to the risk they pose, with higher risk devices subjected to a greater degree of scrutiny. In Great Britain medical devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). The EU Medical Devices Regulation (Regulation 2017/745) (EU MDR) became applicable in EU Member States and Northern Ireland on 26 May 2021. Therefore, the rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain.
When a medical device meets relevant requirements, it can be conformity marked and then placed on the market. From 1 July 2023, a UKCA mark will be needed to place a medical device on the GB market. However, until then manufactures of medical devices can use either the CE mark or UKCA mark. The UKCA mark is not recognised in the EU, EEA or Northern Ireland markets and so products require a CE mark for sale in these markets. Where third party conformity assessment is needed, a UK Approved Body is needed.
For medical devices to be within scope of PAGB membership they must:
For more information on which devices fall into scope of PAGB membership please contact firstname.lastname@example.org.