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...
Revised list of IMDRF codes also includes Annex G (component codes)
The International Medical Device Regulatory Forum (IMDRF) published the last piece of a code system which may be used worldwide for various applicatio...
New MDCG guidance documents!
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-bin...
New and current standards have been harmonized with the current directives!
On 25 March 2020, the Commission adopted three Implementing Decisions on harmonised standards which will allow manufacturers to place on the market de...