Metecon GmbH: Regulatory Compliance in EU market – Medium

Metecon GmbH: Regulatory Compliance in EU market

Metecon GmbH: Regulatory Compliance in EU market

Clinical Evaluation of Medical Devices: A Guide for Beginners

The clinical evaluation of medical devices is a crucial step that plays a key role not only in market introduction but throughout the…

5 min readApr 12, 2024

--

Clinical Evaluation of Medical Devices: A Guide for Beginners

--

Metecon GmbH: Regulatory Compliance in EU market

EU 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 readApr 12, 2024

--

EU Proposal for IVDR and MDR: EUDAMED, Prior Notice Obligation, and Transitional Arrangements for…

--

Metecon GmbH: Regulatory Compliance in EU market

In-house IVD in the focus of the MDCG 2023–1

Does the new, long-awaited MDCG Guidance 2023–1 deliver what it promises? Does it really clarify the practical implementation of Article…

13 min readMar 7, 2023

--

In-house IVD in the focus of the MDCG 2023–1

--

Metecon GmbH: Regulatory Compliance in EU market

MDCG Guidance Document 2022–21: These are the highlights

In 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 readMar 2, 2023

--

MDCG Guidance Document 2022–21: These are the highlights

--

Metecon GmbH: Regulatory Compliance in EU market

Switzerland: New regulation of in vitro diagnostics by IvDO

In the past, the Mutual Recognition Agreement (MRA) between Switzerland and the EU has facilitated cross-border trade in medical devices/in…

6 min readMar 1, 2023

--

Switzerland: New regulation of in vitro diagnostics by IvDO

--

Metecon GmbH: Regulatory Compliance in EU market

Post-market clinical follow-up: Your entry into the PMCF-CER cycle of MDR

The (EU) 2017/745 (MDR) describes the regular update of clinical evaluation through the PMCF report. Therefore, a mechanism is added that…

4 min readFeb 28, 2023

--

Post-market clinical follow-up: Your entry into the PMCF-CER cycle of MDR

--

Metecon GmbH: Regulatory Compliance in EU market

Regulatory Affairs 2023: Outlook on various requirements and target markets

The past year was exciting: It has kept medical device manufacturers on their toes with the implementation of MDR requirements while IVD…

6 min readFeb 6, 2023

--

Regulatory Affairs 2023: Outlook on various requirements and target markets

--

Metecon GmbH: Regulatory Compliance in EU market

Metecon GmbH: Regulatory Compliance in EU market

We share their best tips, research, how-tos and insights in the field of Regulatory Compliance in EU market. https://www.metecon.de

Following

Help
Status
About
Careers
Press
Blog
Privacy
Terms
Text to speech
Teams