CE Marking News and Articles

MDCG publishes MDR Surveillance Guidelines

MDCG publishes MDR Surveillance Guidelines

MDCG publishes MDR surveillance guidelines regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD.

Extension of Delegated Powers MDR & IVDR?

Extension of Delegated Powers MDR and IVDR?

Extension of Delegated Powers MDR and IVDR? – The European Commission wants to extend its delegated powers for five years. This is to be able to amend the MDR and IVDR where the text of the regulations allows.

Polish Medical Device Law Renewed

Polish Medical Device Law Renewed | Graphic by Ellina Goncharova from Alura Group

or Poland’s new medical device law will radically change the current environment for doing business in Poland’s medical device sector. 

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?