An extract of the issues most frequently identified by the BASG when assessing requests for the issue of a certificate of free sale:

• Outdated or incorrectly completed request form
• Incomplete requests
• Incomplete or incorrectly filled overview list of documents
• Missing or out-of-date device list
• Contradictions due to inconsistent information
• Company name differing from the commercial register
• Missing device or trade name
• Missing or insufficient intended purpose
• Labelling does not meet all requirements
• Failure to identify the requested devices in supporting documentation

• Use of an out-of-date request form
• ‘Submitting a request’without sending a completed request form
• ‘Combined requests’ resulting from multiple selections instead of selecting the relevant legal matter
  e.g.: both Directive and Regulation devices ticked

A request may only be submitted for devices falling under a single legal subject area ( e.g. MDR). Accordingly, only a single selection is permitted on the request form.

Requests must be submitted using the current request form and in accordance with the request guidelines.

• Nosupporting documents have been submitted with the request – only the request form has been submitted
• Certain documents are missing entirely 
  e.g.: labelling documents have not been submitted for all devices (UDI-DI level)
• Some documents are out of date 
  e.g.: a Regulation device with instructions for use in accordance with the Directive

Documentation for each device covered by the request must be available for assessment.

The documentation relating to the devices covered by the request may already be on file with the BASG from previous requests – provided no changes relevant to legal requirements have been made – or must be submitted with the current request.

• Incomplete – not all relevant columns have been filled in for all devices
• Use of an out-of-date list – the current list (most recently submitted by the BASG) is not being used for the submission
• Some of the information entered is not up to date
  e.g.: amended documents not marked as such or references to outdated or unsubmitted documents
• Incorrect details 
  e.g.: the device name does not match the information on the Declaration of Conformity (DOC)

Please note: the colour code (see overview-list of documents) for marking changes to ensure traceability.

When preparing the documentation for submitting a request, always refer to the most recent overview-list of documents provided by the BASG, unless this is your first application for devices covered by Directives or Regulations.

• Missing entirely → Scope of the request unknown
• Not kept up to date 
  e.g.: Change to the scope (reduction) during the course of the procedure without updating the device list accordingly

The CFS is drawn up on the basis of the device list. This is a tab in the overview-list of documents for the relevant request, which must be created using the template.

• The information in these documents does not match 
  (request form, overview-list of documents including device list, declaration of conformity, instructions for use, labelling, …)
  
  e.g.: the number of devices listed in the request form does not correspond to the number of devices listed in the device list

Contradictions in the information provided prevent the issue of a certificate of free sale.

The information must be consistent across all the documents submitted.

• The details provided for the economic operator (manufacturer, authorised representative, etc.) do not match the character string in the Commercial Register
  e.g.: use of an abbreviation or alternative spelling of the company name in the labelling

The company name must be stated consistently on all documents in accordance with the wording in the Commercial Register and in EUDAMED.

• Exact correspondence is required (e.g. ‘&’ is not the same as ‘+’).
• Case sensitivity also applies
• Any abbreviations voluntarily included in EUDAMED are not sufficient to meet the legal requirement regarding the need for unambiguous identifiability

• Device designations in the various documents that differ from the device name or trade name
  e.g.: the labelling does not use either the device name or the trade name, but a different device designation

Device and trade names are proper nouns defined in the DOC or the UDI database ; therefore, they must not be translated (e.g. into various languages in the instructions for use)

They must be standardised across all documentation and consistent with the information in EUDAMED.

• is missing from the Declaration of Conformity and/or the Instructions for Use, or does not meet the requirements for an intended purpose
  e.g.: merely a description of the device’s field of application

The intended purpose must be stated in the IFU and, in accordance with Annex IV of the MDR/IVDR, also on the DOC.

‘Intended purpose’ means, in accordance with Article 2(12) of the MDR and IVDR ‘means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation’

This must be clear and unambiguous, so that it is evident whether it fulfils the definition of a medical device (Article 2(1) of the MDR) or an IVD (Article 2(2) of the IVDR) .

• incorrect symbols or designations relating to these
• proportions of the CE marking do not comply with the specific requirements set out in Annex V of the MDR/IVDR

All applicable marking requirements (Annex I, Sections 23.2 and 23.3, Annexes V and VI of the MDR/IVDR, …) must be met.

• In the documentation provided to demonstrate compliance with the requirements for the lawful application of the transitional provisions (Confirmation Letter, Manufacturer’s Self-Declaration, …) the devices covered by them cannot be clearly identified
  e.g.: devices are listed in the Confirmation Letter solely by their basic UDI-DI, even though the device range comprises more than one device per basic UDI-DI
• Discrepancies or contradictions in device names or unique references or identification codes (e.g. REF)

If the device covered by the relevant evidence cannot be identified beyond doubt and are therefore not uniquely identifiable, the evidence for the devices in question is to be regarded as not having been provided. Accordingly, the transitional provisions do not apply to these devices.

The identifiability and traceability of devices is an inherent principle of the MDR (Recitals 4 and 41, as well as Chapter III of the MDR, which, amongst other things, reads ‘IDENTIFICATION AND TRACEABILITY OF DEVICES’) and must be ensured regardless of the transitional provisions.