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...
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...
COVID-19 info!
European Commission Comments for Consideration on COVID-19 info on In Vitro Diagnostic Tests and Their Performance Commission Working Document –...
MDR Delay!
2020.04.24 In writing and set in stone with the publication on the Official Journal of the European Union. Here is the publication. 2020.04.20 On Frid...
No CE marking needed!
On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark relevant for the fighting of the COVID-19 cris...
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...