Simplified CE Marking Procedures Pursuant to MDD, AIMDD, and IVDD

1. Determine directives
2. Verify requirements
3. Need for notified body?
4. Check conformity
5. Technical documentation
6. Affix CE marking

Medical Device Directive (MDD or 93/42/EEC)

As a first step, you need to verify whether your product(s) fall(s) within the definition of a medical device in accordance with Article 1 paragraph 2a) of Directive 93/42/EEC. Second, you need to exclude that your product(s) falls within the definition of an active implantable medical device (Directive 90/385/EEC) or of an in vitro diagnostic medical device (Directive 98/79/EC). Finally, you must verify that no other exclusion clause contained in the first Article of Directive 93/42/EEC is applicable. If all these conditions are fulfilled, Directive 93/42/EEC applies.

• Download Directive 93/42/EEC on Medical devices (MDD) 
• For further information on Directive 93/42/EEC on Medical devices (MDD), please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm
• For a further look at the guidance for medical devices, please visit:http://ec.europa.eu/enterprise/sectors/medical-devices/regulatory-framework/index_en.htm

Active Implantable Medical Device Directive (AIMDD or  90/385/EEC)

As a first step, you need to verify whether your product(s) fall(s) within the definition of an active implantable medical device in accordance with Article 1 paragraph 2a) to c) of Directive 90/385/EEC where also the term “active medical device” is defined. For a definition of “implantable device” see Annex IX, section I.1.2 of Directive 93/42/EEC on medical devices. Secondly, you need to verify that none of the exclusion clauses of Article 1 paragraph 3 to 6 is applicable. If all these conditions are fulfilled, Directive 90/385/EEC applies.

• Download Directive 90/385/EEC on Active Implantable Medical Devices
• For further information on the Directive 90/385/EEC on Active Implantable Medical Devices, please also visit the DG ENTR website dedicated to this subject by following this link:http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm
• For a further look at the harmonized standards for Active Implantable Medical Devices, please visit:http://ec.europa.eu/enterprise/sectors/healthcare/index_en.htm

In Vitro Diagnostic Medical Device Directive (IVDD or 98/79/EC)

As a first step, you need to verify whether your product(s) fall(s) within the definition of an in vitro diagnostic medical device (IVD) in accordance with Article 1 paragraphs 2a), 2b) and 2c) of Directive 98/79/EC. Secondly, you need to verify that none of the exclusion clauses of Article 1 paragraph 3 to 5 are applicable. If all these conditions are fulfilled, Directive 98/79/EC applies.

• Download Directive 98/79/EC on in vitro diagnostic medical devices
• For further information on in vitro diagnostic medical devices, please also visit the DG ENTR website dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm
• For a closer look at the list of harmonised standards, please visithttp://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/iv-diagnostic-medical-devices/index_en.htm

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via Directives – Enterprise and Industry.