Europese guidance-documenten
De Europese Commissie biedt een reeks guidance-documenten aan om belanghebbenden te helpen bij de uitvoering van de MDR.
De guidance-documenten zijn bekrachtigd door de Medical Device Coordination Group (MDCG) en streven naar een uniforme toepassing van de MDR binnen de EU. Deze documenten zijn te vinden op: Guidance - MDCG endorsed documents and other guidance.
Een overzicht van de meest relevante guidance-documenten voor klinisch onderzoek met medische hulpmiddelen vindt u hieronder:
| MDCG 2021-6 | Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation |
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| MDCG 2020-13 |
Clinical evaluation assessment report template |
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MDCG 2020-10/2 MDCG 2020-10/1 |
Guidance on safety reporting in clinical investigations Appendix: clinical investigation summary safety report form |
| MDCG 2020-8 | Guidance on PMCF evaluation report template |
| MDCG 2020-7 |
Guidance on PMCF plan template |
| MDCG 2020-6 |
Guidance on sufficient clinical evidence for legacy devices |
| MDCG 2020-5 | Guidance on clinical evaluation – Equivalence |
| MDCG 2019-9 |
Summary of safety and clinical performance |
| MDCG 2023-1 | Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 |
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| MDCG 2021-3 |
Questions and answers on custom-made devices |
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| Infographic | Is your software a medical device? |
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| MDCG 2020-1 | Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software |
| MDCG 2019-16 revisie 1 |
Guidance on cybersecurity for medical devices |
| MDCG 2019-11 | Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 |
| Manual on Borderline |
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v1 Background note on the use of the Manual on borderline and classification for medical devices under the Directives. |
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| MDCG 2022-5 | Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices |
| MDCG 2021-24 | Guidance on classification of medical devices |
| Helsinki Procedure | Helsinki Procedure for borderline and classification under MDR & IVDR |