| Size | 155.12 KB |
| Downloaded | 1 times |
| Last Updated | 11 June 2020 |
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Category: EU MDCG
2020-10-1 Guidance on safety reporting in clinical investigations
| Size | 261.23 KB |
| Downloaded | 1 times |
| Last Updated | 11 June 2020 |
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2020-9 Regulatory Requirements for Ventilators and Related Accessories
| Size | 901.45 KB |
| Downloaded | 3 times |
| Last Updated | 11 June 2020 |
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2020-8 Guidance on PMCF Evaluation Report Template
| Size | 680.75 KB |
| Downloaded | 2 times |
| Last Updated | 11 June 2020 |
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2020-7 Guidance on PMCF Plan Template
| Size | 705.46 KB |
| Downloaded | 2 times |
| Last Updated | 11 June 2020 |
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2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices
| Size | 860.67 KB |
| Downloaded | 2 times |
| Last Updated | 11 June 2020 |
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2020-5 Guidance on Clinical Evaluation – Equivalence
| Size | 1.10 MB |
| Downloaded | 1 times |
| Last Updated | 11 June 2020 |
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2020-4 Notified Body Audits during COVID-19
| Size | 357.50 KB |
| Downloaded | 3 times |
| Last Updated | 11 June 2020 |
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2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
| Size | 1.03 MB |
| Downloaded | 3 times |
| Last Updated | 11 June 2020 |
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2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
| Size | 898.86 KB |
| Downloaded | 4 times |
| Last Updated | 11 June 2020 |
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