On 17 June 2026, the Official Journal of the EU released Commission Implementing Decision (EU) 2026/1231. This Decision amends the annex to Implementing Decision (EU)…
New harmonised standard: updated EU authorised representative symbol to EU-REP
Following today’s publication in the Official Journal of the EU, EN ISO 15223-1:2021/A1:2025 is officially harmonised. ISO 15223-1:2021 (Amd. 1:2025) was updated by the International…
New harmonised standards under the MDR and IVDR
On 30 January 2026, the Official Journal of the European Union published two new Implementing Decisions. Commission Implementing Decision (EU) 2026/193 and Commission Implementing Decision…
Harmonised standards for surgical clothing and drapes, medical face masks and sterilizers
Today, 20 October 2025, the Official Journal of the EU released Commission Implementing Decision (EU) 2025/2078. This Decision amends Implementing Decision (EU) 2021/1182 to include…
New harmonised standards for medical devices and IVDs
On 9 and 10 April 2025, the Official Journal of the EU published references to standards for medical devices. The standards address conformity of medical…
Public consultation on common specifications for IVDs
From 19 August 2024, the European Commission opened a public consultation on common specifications for certain vitro diagnostic medical devices. For four weeks, until 16…
Updated guidance on standardisation for medical devices
In July 2024, the Medical Device Coordination Group (MDCG) updated its guidance MDCG 2021-5 on standardisation for medical devices, first published in 2021. In the…
IVDR Joint Implementation Plan has been published!
The Medical Devices Coordination Group (MDCG) has issued a joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR). This plan…
MDR & IVDR: New harmonised standards
On 5 July 2023, the Official Journal of the European Union published two new harmonised standards for sterilisation under the Medical Devices Regulation (MDR )…
MDR: Harmonised standards for QMS and risk management
Since May 26, 2021, the medical device sector experienced a great change. The new Regulation replaced the previous Directive and from that date, manufacturers of…