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MDR TECHNICAL FILE GAP ASSESSMENT

We identify the GAPs and Guide appropriate measures

Medical Device Labeling

Medical Device Labeling is complex and needs appropriate information and knowledge on how and what and, what should communicate with users via labels or IFU or Manuals.

MDD & MDR difference in labeling requirements

MDD 93/42/EEC Annex 13.1 states each device must be accompanied by the information needed to use it safely and properly taking account of the training and knowledge of the potential users of the medical device manufactured and sold by your firm.
MDR 2017/745 sec 23.1(a) states the medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose, and the technical knowledge, experience, education or training of the intended user(s).
In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams wherever applicable by the medical device manufacturer.

MDR Labeling Challanges

It’s understood that the new EU regulation for medical devices will have major implications for the labeling operations of every manufacturer that trades in the EU.

 

The definition of ‘label’ in MDD to include Instructions for Use and user manuals only but in EU MDR introduces additional requirements that need to be included on primary, secondary & tertiary sticky labels or nonsticky labels forcing organizations to design information panels. manufactures must understand it’s both a design and a data challenge, and must quickly be addressed before the extended dates of MDR 2017/745 entry on May 2021.

  • Medical Device symbol to indicate the device is a medical device.
  • Significant label redesign to adjust spacing differences to accommodate warning & precautions.
  • Method of supply of instructions for use must be provided on the packaging for each unit and for fixed medical devices, on-device itself.
  • Display of URL for accessing eIFU
  • Single-use devices must detail the maximum possible time that can be reprocessed as well as the number of times the individual device has been reprocessed to date.
  • Devices with a presence of carcinogenic, mutagenic, or toxic to reproduction (CMR) substances must declare on the label.
  • All devices that incorporate a medical substance or tissues/cells or their derivatives must clearly indicate on the label.
  • The biggest challenge, MDR mandates that all warnings relating to a device must be printed on the label.
  • Every active implantable device must have its own unique serial number. Other implantable devices will require a serial or lot number that leads to a data-led labeling system.
  • The MDR requires a Global UDI initiative similar to already implemented FDA UDI rules.

Medical Device Label Review

Medical Device label review consists of a review of your present label in accordance with US FDA or EU MDR / EU IVDR regulation.

It does not involve the development of a new label or guidance for the development of a new label. Check our pricing below. (The fees applicable for both EU & US FDA)

  • Class I Medical Device review : $ 650
  • Class Is / Im / Ir / IIa Medical Device review : $ 850
  • Class IIb Medical Device review : $ 950
  • Class IIII Medical Device Review : $ 1050
  • Class A IVD Device review : $ 650
  • Class B / C  IVD Device review : $ 850
  • Class D IVD Device review : $ 1050

 

Medical Device Symbols

There are multiple languages in EU territory, which creates the necessity to use symbols. The use of symbols on the information panel / label is a substitute to written language and is detailed in annex 1 chapter III 23.1.h of MDR Regulation.