CE Marking News and Articles

MDCG Publishes IVDR Guidelines MDCG 2022-6

MDCG Publishes IVDR Guidelines MDCG 2022-6

MDCG publishes IVDR surveillance guidelines MDCG 2022-6, regarding the transitional provision under Article 110(3) of the IVDR. The aim of this guidance document is to provide clarification on the concept of “significant changes in the design and intended purpose” under IVDR Article 110(3).

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.