Key Terms and Concepts in the Medical Device Regulation – Vigilance The vigilance requirements under the EU’s medical device regulations c...
MDCG Guidance Document on IVD classification
MDCG guidance document on IVD classification If you’re involved in the manufacture or sale of in vitro diagnostic medical devices (IVDs) in the ...
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...
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...
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...
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...
Products without an intended medical purpose!
Products without an intended medical purpose! The regulation (EU) 2022/2346, released on 1 December 2022, lays down common specifications for the grou...
EU MDR Bridge
EU MDR Bridge Deadline/transition – further info! What else happened last Friday, next to the proposed extension of the MDR Deadline for legacy ...
Q & A – new Manufacturer Incident Report (MIR) Form
In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website....
Exciting developments regarding Harmonized Standards!
M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the Eu...
