Technical Documentation  – Additional requirements

Medical Devices

On top of the general guidelines, additional requirements apply depending on the type of Medical Device.

MDD Class I sterile:

You must make available any other information for the particular conformity assessment procedure, such as Approved Body approval and quality system documentation.
You will have to find a suitable Approved Body to get approval for the aspects of manufacturing concerned with securing and maintaining sterile conditions. You can only ask one Approved Body at any one time for approval of particular product ranges.


Its use in the design and construction of a medical device must be justified in the technical documentation. This is because phthalates can be carcinogenic, mutagenic or toxic to reproduction. Justification must take into account the risk-benefit analysis of the use of such a substance.
 If justified, then the instructions for use must include information on any risks associated with using a product that contains phthalates.
Must be labelled in accordance with essential requirement 7.5 of Part II of the UK MDR 2002, Annex I (as modified by Part II of Schedule 2A to the UK MDR 2002) if it is intended to:
  • Administer and/or remove medicines, body fluids or other substances to or from the body;
  • Transport and store medicines, body fluids or other substances that will be administered.
Example: Class I device where phthalates could be an issue is the tubing in an administration set

Class I devices with a measuring function:

Devices that are either syringes with volume indicators or they are a device that measures a physiological parameter and display or indicate the value in a unit of measurement appropriate to the intended purpose. Examples include thermometers, eye tonometers, and lung function monitors including vital capacity meters.
Attention! Devices incorporating indicators that merely show a change in level or state without indicating a specific value, or indicate a specific value of no direct relevance to patient safety, do not exhibit a measuring function in terms of the UK MDR 2002.
  • Manufacturers need to employ a suitable Approved Body to get approval for the aspects of manufacturing concerned with the measuring requirements (for example calibration and inspection).
  • Guidance document MEDDEV 2.1/5 provides additional information on devices with a measuring function.

Upper Class

UK Approved Body intervention is needed if your medical device falls into Class II, IIb or III, or is a Class I device that is sterile or has a measurement function, you need to contact a UK Approved Body that can carry out a conformity assessment for the specific classification. 

Appoint Obelis UK Ltd. as your UK RP today.

Appoint Obelis UK LTD. as your UK RP