CE Marking News and Articles

New UK Guidance Proposals

New UK Guidance Proposals: There are new proposals published for businesses in regard to the designated standards of  Personal Protective Equipment, Pressure Equipment, and Recreational Craft.

New UK Guidance Proposals: On 22 April 2022, there are new proposals published for businesses in regard to the designated standards of 
Personal Protective Equipment, Pressure Equipment, and Recreational Craft.

EU MDR 2017/745 What Changed?

EU MDR 2017/745 What Changed in regard to the Medical Device Directive and how to implement them in your current quality management system?

The new medical device regulation, EU MDR 745/2017, has several additional criteria in regard to previous legislation. This new regulation also has a stronger connection to EN ISO 13485:2016. What modifications have been made to the prior medical device regulation, and how must you implement these changes in your current quality management system?