Metecon GmbH: Regulatory Compliance in EU marketClinical Evaluation of Medical Devices: A Guide for BeginnersThe clinical evaluation of medical devices is a crucial step that plays a key role not only in market introduction but throughout the…5 min read·Apr 12, 2024----
Metecon GmbH: Regulatory Compliance in EU marketEU Proposal for IVDR and MDR: EUDAMED, Prior Notice Obligation, and Transitional Arrangements for…The implementation of the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) continues to be a significant challenge…4 min read·Apr 12, 2024----
Metecon GmbH: Regulatory Compliance in EU marketIn-house IVD in the focus of the MDCG 2023–1Does the new, long-awaited MDCG Guidance 2023–1 deliver what it promises? Does it really clarify the practical implementation of Article…13 min read·Mar 7, 2023----
Metecon GmbH: Regulatory Compliance in EU marketMDCG Guidance Document 2022–21: These are the highlightsIn case you haven’t heard yet, the MDCG 2022–21 — Guidance on Period Safety Update Report (PSUR) according to Regulation (EU) 2017/745…4 min read·Mar 2, 2023----
Metecon GmbH: Regulatory Compliance in EU marketSwitzerland: New regulation of in vitro diagnostics by IvDOIn the past, the Mutual Recognition Agreement (MRA) between Switzerland and the EU has facilitated cross-border trade in medical devices/in…6 min read·Mar 1, 2023----
Metecon GmbH: Regulatory Compliance in EU marketPost-market clinical follow-up: Your entry into the PMCF-CER cycle of MDRThe (EU) 2017/745 (MDR) describes the regular update of clinical evaluation through the PMCF report. Therefore, a mechanism is added that…4 min read·Feb 28, 2023----
Metecon GmbH: Regulatory Compliance in EU marketRegulatory Affairs 2023: Outlook on various requirements and target marketsThe past year was exciting: It has kept medical device manufacturers on their toes with the implementation of MDR requirements while IVD…6 min read·Feb 6, 2023----