Products without an intended medical purpose! The regulation (EU) 2022/2346, released on 1 December 2022, lays down common specifications for the grou...
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- EU IVDR (11)
- EU MDR (22)
- News (59)
- Switzerland (10)
- UK (10)
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 ...
IvDO adopted!
It is confirmed. Switzerland adopted the new Regulation on In-vitro Diagnostics (IvDO), which mainly refers to the IVDR. The provisional text in Germa...
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...
New documents published by the European Commission!
We will comment based on the feedback and questions MDSS may receive. State of play of joint assessments of Notified Bodies in the medical device sect...
Warning – For risk class I devices!
Products, which stay class I under the MDR, must be in full compliance by May 26 2020! MDSS concern: Some clients seem to be under the impression that...
