Informazione tecnica HSE / 25 ° anno
/ Documenti disponibili:
44.821
/ Documenti scaricati: 32.887.669
/ Documenti scaricati: 32.887.669
ID 11637 | 28.09.2020
- Note Technical Documentation Regulation (EU) 2017/745 (MDR)
- Example Structure Model Rev. 1.0 sept. 2020
The following structure is based on Regulation (EU) 2017/745 (MDR) but is also suitable for technical documentation according to Directive 93/42/EEC.
1. Device description and specification
1.1. General description of the device, its variants and its intended purpose
1.1.1. Name and address of the manufacturer
1.1.2. Overview of devices/ device groups/device types e.g. table with designation and reference to the REF number, including UDI-DI (if applicable)
1.1.3. All trade names under which the device is placed on the market
1.1.4. Description and specifications of the device including its intended purpose, indication(s), contraindication(s) and warnings, the intended patient group and the medical conditions to be diagnosed/treated/monitored
1.1.5. UMDNS/GMDN classification (if applicable)
1.1.6. Technical specifications of the device, such as characteristics, dimensions and performance attributes of the device
1.1.7. Variants/components/configurations and accessories of the device
1.1.8. Exact software version (if applicable)
1.1.9. Explanations of new characteristics and new intended purposes/indications
1.2. UDI (as soon as implemented or obligatory)
Description of the basis-UDI-DI, taking into account all variants covered by the technical documentation
Until the complete implementation of the UDI requirements at least a clear representation of all variants covered by the TD (sizes, forms, coatings, etc.).
1.3. Designation / Classification
Justification for the designation as a medical device and description of the classification of the device including justification for on the applied classification rule(s), exact identification of the applied indent, statement for the classification
1.4. Declaration of Conformity (DoC)
DoC according to Annex IV MDR or according to MDD (considering EK-MED-Beschluss 3.9 A4). For initial certifications (e.g. MDR) the DoC has to be filed in draft status.
....
segue in allegato
Certifico Srl - IT | Rev. 0.0 2020
©Copia autorizzata Abbonati
Collegati
Rettifica del regolamento delegato (UE) 2019/2014 della Commissione, dell’11 marzo 2019, che integra il regolamento (UE) 2017/1369 del Parlamento europ...
EN 280 Piattaforme di lavoro mobili elevabili - Ed. 2009
Calcoli per la progettazione - Criteri di stabilità - Costruzione - Sicurezza - Esami e prove
La norma specifica i r...
ID 19432 | 13.05.2025 / Download scheda allegata
Documenti elaborati sul Regolamento macchine 2023, Regolamento (UE) 2023/1230 del Pa...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024