Updates from the Medicines and Healthcare Products Regulatory Agency on the withdrawal of several UK-based notified bodies.
News
Joint implementation plan on the new Medical Devices Regulation – (EU) 2017/745 (MDR)
With the 26 of May around the corner, and as response to the call from the Council of the EU (EPSCO), the MDCG (Medical Device Coordination Group) has issued a document stating the challenging joint responsibility Member States and the Commission have, together with the concerned stakeholders, to ensure that the new legislation on medical devices is operational from the aforesaid date.
The Cosmetics Borderline with 3 new entries
Read more about the updated manual with guidelines for nail care and massage products, and essential oils as cosmetics on the EU market.
Scientific Committee on Consumer Safety issued opinion on Zinc Pyrithione
Scientific Committee on Consumer Safety issue opinion on the use of zinc pyrithione in hair conditioners, shampoos, skincare products, and other EU cosmetics.
Formula for implementing MDR
With the May 26th deadline approaching, learn more about the compliance path for medical devices under EU Medical Device Regulation 2017/745.
The latest news on the approval process of the UK Medical Device law
Brexit negotiations are on hold. EU trade talks could be postponed due to the coronavirus. But the new UK law on Medical Devices has been progressing.
Irish MedTech Priorities for the Next Government
The Irish Medtech Association proposes two key priorities for the next government.
Slide 6
Swiss MDR Deadline has passed! Appoint a Swiss Authorized Representative now! Get in touch
Slide 3
Your Consultant on UK Regulations We have recently launched Obelis UK Limited to support the…
MHRA guidance for manufacturers on Clinical investigations of medical devices
Guidance for medical device manufacturers on clinical investigation for product release on the UK market from the Medicines & Health Products Regulatory Agency.