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MDRNews

Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation

Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation The EU’s Medical Device Regulation (MDR) has brough...

MDSS January 31, 2023
NewsSwitzerland

Handling of Certification Gaps according to MDCG 2022-18

Handling of Certification Gaps according to MDCG 2022-18 Introduction The Medical Device Coordination Group (MDCG) has released a new document that pr...

MDSS January 25, 2023
MDCG documentsMDRNews

Standard Fees for Notified Bodies under MDR and IVDR

Standard Fees for Notified Bodies under MDR and IVDR The Medical Device Coordination Group (MDCG) has released a new document, MDCG 2023-2 This docume...

MDSS
MDCG documentsMDRNews

Proposal for amending the medical devices transition extension was published!

The proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transi...

MDSS January 9, 2023
MDCG documentsMDRNews

The MDCG Position Paper On The Temporary Use Of Article 97 Of The MDR

Article 97 – Expiring medical device certificates (Temporary application of Article 97 MDR) The Medical Devices Coordination Group’s (MDCG...

MDSS January 5, 2023

Recent Posts

  • Medtech Europe position paper on the future of Europe’s Medical Technology Regulations!
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  • Advantages of conducting business in the UK. Possible under the MDR?

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