EUrope mdr techincal documentation

Start selling Class I Medical Devices in Europe or update your Technical Documentation to meet MDR. 

We can write your:

• Technical Documentation Report
• Clinical Evaluation Report
• Post Market Surveillance Report
• Declaration of Conformity

The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements.

If you are the manufacturer, there are certain rules that must be followed when placing a product on the market; you must:

• Prepare the technical documentation before placing a product on the market
• Ensure the technical documentation is made available to the market surveillance authorities (should they request to see it) as soon as the product is placed on the market
• Keep the technical documentation for 10 years from the date the product is placed on the market (unless explicitly specified otherwise)

The technical documentation is necessary to prove the product meets the essential requirements and therefore justify and support an EU declaration of conformity. You need this documentation in order to affix the CE marking to the product.

The technical documentation should include at least:

• Your name and address, or that of any authorized representatives.
• A brief description of the product.
• Identification of the product, such as its serial number.
• The name(s) and address(s) of the facilities involved in the design and manufacture of the product.
• The name and address of any notified body involved in assessing the product's conformity.
• A statement of the conformity assessment procedure that has been followed.
• The EU declaration of conformity.
• Product labeling and usage instructions.
• A statement of the relevant regulations to which the product complies.
• Identification of the technical standards with which compliance is claimed.
• A list of parts.
• Test results.