Product directives are joint rules that have been put in place to simplify trade to and between the member countries of the European Union.  Before the CE Mark may be affixed to a medical device and legally sold within the European Union, the manufacturer or exporter must complete the following:

• Prepare Technical Documentation (Technical File) to show the product’s compliance with applicable essential requirements and conformity assessment procedures of the applicable device directive
• Register their device with the appropriate Competent Authorities
• Receive a device-specific CE Certificate from a Notified Body (Class I devices do not require a certificate from a Notified Body)

Navigating the CE marking process does not have to be painstaking. In fact, RASOO makes it as easy as the following steps:

1. Classify your product - Class I, IIa, IIb, and III according to the classification rules in Annex IX of the MDD:

• Class I. Devices with low risk such as external patient support products.
• Class IIa/b. Devices with medium risk such as electro-medical devices.
• Class III. Devices with high risk such as cardiovascular catheters.

*Note that: Some Class I and all Class IIa, IIb, and Class III devices require Notified Body approval.

2. Determine your certification process based on your device class

3. Fulfill the essential requirements - Ensure that your medical device fulfills the essential requirements in Annex I of the Medical Device Directive.

4. Establish a monitoring system - As a manufacturer, you are required to monitor your products once they are on the market, in case accidents involving your products occur.

5. Establish an accident reporting system - If an accident or near-accident involving any of your products takes place, you are obligated to report this to the authorities.

6. Issue a Declaration of Conformity

7. Save the documentation for five years - The new revision of the MDD requires that records for implantable devices be kept for 15 years. Declaration of conformity, technical documentation, reports, and certificates from the Notified Body etc. must be kept for at least five years after the product has been taken out of production.

8. Register with the appropriate authorities in Europe

The Medical Device Directive 93/42/EEC (MDD) is filled with confusing rules, device classifications, and conformity requirements. RASOO has helped countless medical device manufacturers gain market access into the European Union. Our experts know your product and the requirements you must meet - from the MDD certification process to the standards related to your device class.

In order to market your medical device within the member states of the European Union, your product must comply with the essential requirements of the MDD. Compliance with harmonized standards (such as EN 60601-1-2:2001 for EMC, and EN 60601-1 for electrical safety) can provide assumption of conformity to specific requirements. 

In simple terms, the aim of the MDD is:  

• To define the essential requirements that medical devices must meet before being placed on the market
• To establish conformity assessment procedures based on device classifications
• To create tracking and reporting mechanisms available to national authorities to ensure and protect public health

As part of the MDD’s essential requirements (Annex I), you must also provide the following:

• Technical Documentation (Technical File) - Technical documentation should contain full construction details and validation/verification data for your medical device. This will prove that you comply with the essential requirements of the MDD.
• Risk Assessment - Your product’s risk assessment must include a construction evaluation, materials used, bio-compatibility analysis, infection and cross-infection risks, and potential risks during use. The resulting documentation becomes part of the Technical File.
• Quality System - Your organization must meet the quality system requirements of the MDD. Conformity to ISO 13485, which is a harmonized standard in the EU, is a way to demonstrate conformity to the quality system requirements of the MDD for those annexes applicable.

Depending on your product classification, you may also need Notified Body approval.  We are the European Union based Notified Bodies to the MDD

Once you have met all applicable requirements, it is your responsibility to show conformity with the Medical Device Directive by affixing the Ce Mark  to your device.

RASOO has the expertise to help you navigate the IVDD quickly, cost effectively, and successfully. With three Notified Bodies in Europe, RASOO has helped countless in-vitro diagnostic device manufacturers gain market access into the European Union.
The In-Vitro Diagnostic Directive (IVDD) 98/79/EC addresses the essential requirements that an in-vitro diagnostic device must meet before being marketed within the European Union. The requirements called out within the IVDD are essentially a grouping of requirements covered within the Active Implantable Medical Devices Directive and Medical Devices Directive (MDD) 93/42/EC.

The scope of the IVDD covers all in-vitro diagnostic devices and their accessories. An in-vitro device is defined as any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system to be used in-vitro for the examination of blood or tissue specimens.

In comparison to the MDD, the IVDD places greater emphasis on the potential risk involved during the use of the product. With that, the intended use and the potential risks must be outlined in a risk assessment. In addition, the IVDD calls out specific design, manufacturing, packaging, and labeling requirements.

Meeting the IVDD standards is as easy as the following simple steps:

1. Determine your product group based on its function

Self testing devices; such as those products deemed for home use
Reagents and reagent products, including calibrators and control materials for determining blood groups or the detection and confirmation of HIV or Hepatitis infection - Annex II, List A Device
Reagents for blood typing and self-diagnosis devices - Annex II, List B Device
Products that do not fall into the first three groups
2. Determine the essential requirements based on your product group

3. Fulfill the essential requirements - Depending on your product group, you will need to provide/complete a combination of the following essential requirements:

Provide technical documentation (technical file) containing full construction details of your in-vitro diagnostic device.
Show compliance to the essential requirements and/or applicable harmonized standards.
Provide a risk assessment, including construction evaluation, materials used, bio-compatibility analysis, infection, and cross-infection risks.
Meet the quality system requirements of the Directive.
4. Establish a monitoring system - As a manufacturer, you are required to monitor your products once they are on the market in case necessary updates must be made according to updated requirements of the IVDD.

5. Establish an incident reporting system - If an incident or near-incident involving any of your products takes place, you are obliged to report this to your local governing body for medical devices.

6. Prepare a Declaration of Conformity / Apply CE Marking

7. Register with the local governing body for medical devices

Contact us to see how RASOO can help your organization with CE Marking for Medical Devices.