Implementation Status of the Medical Devices Regulation: a Call to Action
From MedtechEurope – Implementation Status of the Medical Devices Regulation: a Call to Action
Published in Medical Device Regulation MDR and MedTech Europe
More from Medical Device Regulation MDRMore posts in Medical Device Regulation MDR »
- EU – Guidance – Clinical evaluation assessment report template
- EU – Team NB position statement on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III)
- UK – MHRA – Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under MDR
- EU – COMMUNICATION FROM THE COMMISSION Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745
- EU – Mandate M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the CEN and the CENELEC in support of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
More from MedTech EuropeMore posts in MedTech Europe »
- From MedtechEurope – IVDR – MDR Labelling differences: what symbols apply to IVDs
- Medtech Europe presentation – – Industry Perspective on the Implementation Status of the MDR/IVDR
- Medtech Europe guidance – Use of Symbols to Indicate Compliance with the MDR
- Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR)
- MedTech Europe Statement on the Implant Files
Be First to Comment