August 26, 2022
The MDCG has proposed solutions, due to concerns about eventual lack of medical device supply in Europe. Find out how the requirements are being eased.
August 12, 2022
The EU Commission proposed classifications for certain products without a medical claim, e.g., liposuction equipment & hair removal lasers. Find the new classifications here.
August 4, 2022
The Blue Guide is an important tool to interpret EU Regulations, such as the definition of 'placing on the market'. What is the impact of the 2022 update?
July 27, 2022
The EU issued Northern Ireland Protocol infringements against the UK. The Protocol allows free movement of goods at the UK/EU border in Ireland. Is that now at risk?
July 15, 2022
The Medical Device Coordination Group (MDCG) published new guidance on alternative solutions until EUDAMED is fully funcational. Find out the requirements here ...
July 11, 2022
This month the EU Commission updated the EUDAMED 'go-live' date to Q2 2024, delaying EDUAMED by another year. Find out the new mandatory EUDAMED dates here ...
July 8, 2022
The EU Commission released three new IVDR Implementing Regulations: EU Reference Laboratory (EURL) fees / criteria and Common Specifications for Class D devices.
June 23, 2022
The EU Competent Authorities issued a new guidance document June 2022 regarding medical device Certificates of Free Sale/Export Certificates. Read more here ...
June 13, 2022
June 2022 MDCG Position Paper Warns: no further extensions will be granted to legacy devices. If you wait too long to MDR CE mark, you may temporarily be off the EU market while you wait for Notified Body availability ...