Information for certification to Directive 93/42/EEC Are of in EXPLANATION of terms: Yes you “manufacturer” “medical devices” ☐ Europe? Medical device see Art. 1 (2) a) – No Class - see Annex IX and Are medical devices of classes III, IIb, IIa, or class I (sterile or with ☐ measuring function) placed on the European market under the name skip to No. 4 Manufacturer see Art. 1 (2) f) – of your organisation as manufacturer, or is this planned in near future? Are you located outside Europe (EU/EEA/CH)? EU Representative see Art. 1 (2) j) Yes – ☐ (any natural or legal person established in the Community who, explicitly designated by the (EU Representative) details in 2.4 manufacturer, acts and may be addressed by authorities and bodies in the Community If you, as manufacturer, are located outside the EU/EEA/CH, please instead of the manufacturer with regard to the latter's obligations under this Directive) No provide details on your EU Representative in No. 2.4. ☐ DIMDI registration Manufacturer DE/00000__________ – if manufacturer located in Germany EU Representative DE/00000__________ – if EU Representative located in Germany -Part Medical Devices EU- Use the form 410.141 Basic Data List of Medical Devices List of Medical Devices – Table Medical Devices EU Attached see No. 2.2 – ☐ Location of all evidence At what locations are all records required by your QMS available, including product documentations according Directive 93/42/EEC Annex II No. 3, Annex V No. 3 or Annex VI No. 3?
Information for certification to Directive 93/42/EEC Are you “manufacturer” of “medical devices” in Europe? Are medical devices of classes III, IIb, IIa, or class I (sterile or with measuring function) placed on the European market under the name of your organisation as manufacturer, or is this planned in near future? ☐ Yes ☐ No skip to No. 4 EXPLANATION of terms: Medical device – see Art. 1 (2) a) Class - see Annex IX and Manufacturer – see Art. 1 (2) f) Are you located outside Europe (EU/EEA/CH)? (EU Representative) If you, as manufacturer, are located outside the EU/EEA/CH, please provide details on your EU Representative in No. 2.4. ☐ Yes details in 2.4 ☐ No EU Representative – see Art. 1 (2) j) (any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive) DIMDI registration Manufacturer – if manufacturer located in Germany DE/00000__________ EU Representative – if EU Representative located in Germany DE/00000__________ List of Medical Devices -Part Medical Devices EU- ☐ Attached – see No. 2.2 Use the form 410.141 Basic Data – List of Medical Devices Table Medical Devices EU Location of all evidence At what locations are all records required by your QMS available, including product documentations according Directive 93/42/EEC Annex II No. 3, Annex V No. 3 or Annex VI No. 3?
410_14e_Basic_Data_Organisation_MD.docx