UKCA vs CE MARK, Product Safety and Compliance Update February 23-2022
The UK-based OPSS published an update on 23 February 2022 on some of the forthcoming changes regarding the UKCA vs CE Mark. Here is a summary of this update
EU
Amendments Toy Safety Directive
The European Commission has made changes to the list of harmonized standards under the Toys Safety Directive. These have been published on 16-11-2021. In this article we summarize the standards on the list that have been amended.
UK Postponement Implementation Import Controls on EU Products
UK control postponement; The start date for new import regulations for products entering into the country from the EU will be delayed.
LEVA-EU Disputes Dutch bill for LEV’s
LEVA-EU disputes Dutch bill for LEV’s. It believes the proposal violates EU law and requests Dutch government to abandon the LEV approval framework.
The Future of Quality in Product Safety and Product Compliance
What is the role of quality assurance and quality management in product safety and product compliance? How does quality management help to make the legal responsibilities of economic operators easier? What developments can we expect in the near future? Mr. Han Zuyderwijk and Mr. Anthony Hayes will be discussing these subjects in a Livestream on Youtube and Facebook.
‘UK Medical Devices Regulation Needs Reform’
The UK Medical Devices Regulation urgently needs reform. This is the conclusion of the UK’s Regulatory Horizons Council in their report on Medical Devices published on the 19th of August 2021. Read their recommendations here.
European Union Harmonized Standards For Medical Devices
The Medical Device Coordination Group of the European Commission has issued new recommendations on the role of standards in the medical device industry.