Professional Documents
Culture Documents
Netherlands Poland
Portugal Romania Slovakia Slovenia Spain Sweden United Kingdom
2
9/10/07
The fourth state, Switzerland, has bilateral agreements with the EEA.
9/10/07
Based on compliance not notice or approval No EU centralized authority Different approach to determining standard of care: national health systems,
9/10/07 4
Shared
EU specific
ISO 13485 Few definitions Quality Planning
Shared
Purchasing Product Identification Process Control Inspection Measurement & Test Equipment Nonconforming Product Corrective & Preventative Action
EU specific
9/10/07
Shared
Packaging
EU specific
Translation
Shared
Servicing Statistical Techniques
EU specific
ISO 14971 Biocompatibility Electrical Safety Electromagnetic Compatibility MDD Essential Requirements
9/10/07
Shared
Sterile Packaging shelf-life sterile barrier shipping Sterilization Validation
EU specific
9/10/07
Shared
EU specific
ISO 14155-1, -2 Audits initial continuing
9/10/07
10
The CE Mark
Possibly Communitee Europen, French for European Community. Could be Conformit Europen. Invented by some bureaucrat in Brussels. Officially, just a logo and has no linguistic meaning.
9/10/07 11
I II
Class I (Sterile)
disposable surgical instruments urine drainage bags
9/10/07 19
9/10/07
20
certify full quality assurance system certify production quality assurance system certify final inspection and testing; or exam and test sample products.
23
9/10/07
25
Technical Construction File (Class I & II) or Design Dossier (Class III)
Essential Requirements Analysis
Product design specifications Hazard and risk analysis Verification and validation reports
Engineering test reports Laboratory reports Clinical validation
Product labeling
A combination of elements from the Design History File and the Device Master Record
9/10/07 26
Declaration of Conformity
Document created by the person placing the device on the market that clearly identifies:
The manufacturer or their AER Manufactures or AERs European Address The device (models, serial numbers, lots, etc.) The applicable directives The major standards complied with Signed by a responsible authority
Included in the device labeling, usually in the instructions for use and shipping documents
9/10/07 27
9/10/07
28
German Dutch + German + French (All three must be used for patient instructions) English, Bulgarian for self-test devices only. Croatian Non-professional use devices in Greek. Professional Use devices in Greek or English Czech Danish Estonian
29
9/10/07
30
Latvian for professional use; English or German is accepted German Lithuanian French
9/10/07
32
9/10/07
33
Graphics!
9/10/07
34
Sell products F.O.B. in market countries, others in the EU can purchase across borders Require training for professionals and service personnel where more complete materials can be provided in English
9/10/07
35
Post-Market Surveillance
Manufacturer must establish systems to
Record and analyze customer responses Process customer complaints Collect, report and analyze any adverse events Actively monitor use and abuse of the product
9/10/07 36
A point of contact within the EU where the Competent Authorities can serve notices Generally not a sales office or a business facility Required to be shown on all labeling Only one required for the entire EU
Establishes the country of legal jurisdiction for criminal and civil actions, including insurance
Should be knowledgeable in the mechanics of the MDD May be required to respond within 2-3 days with technical file
9/10/07 37
Questions?
Ask the EU Commission: ec.europa.eu/enterprise/medical_devic es/index_en.htm
9/10/07
38