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(EU)2021/2226 explained: Electronic Manuals for Medical Devices

(EU)2021/2226 explained: Electronic Manuals for Medical Devices – published on cemarking.net –

Harmonized Standards Toy Safety Directive: Important Validation Announcement

The validation date of some of the harmonized standards under the Toy Safety Directive has been exceeded. This article refers to an outline of the changes for your convenience.

Functions and Effects of European Standards: The Final Study

In 2021, the European Commission published its roadmap for a new standardization strategy. The aim of the new strategy is to address the challenges facing the European standardization system. During an 18-month period, different categories of stakeholders from EU and EFTA Member States were consulted as part of this roadmap. The main results are now published in this study.

New IVDR Notified Body in Slovakia

New IVDR Notified Body in Slovakia: 3EC International has been approved to undertake IVDR conformity assessments.

MDCG Publishes IVDR Guidelines MDCG 2022-6

MDCG publishes IVDR surveillance guidelines MDCG 2022-6, regarding the transitional provision under Article 110(3) of the IVDR. The aim of this guidance document is to provide clarification on the concept of “significant changes in the design and intended purpose” under IVDR Article 110(3).

Philips Respironics Voluntarily Recall of V60 Ventilator Product Family

Philips Respironics Voluntarily Recall of V60/V60plus and V80 | Photo Source: Philips

Philips Respironics voluntarily recall of V60 fan product family – publication on cemarking.net – May 4, 2022

MDCG publishes MDR Surveillance Guidelines

MDCG publishes MDR surveillance guidelines regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD.