In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website....
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Regulation (EU) 2017/745 – Consolidated text!
The consolidated text also includes the MDR delay. From now on we would not expect any major changes anymore. Consolidate text (EN).pdf For other lang...
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...