New Regulation Proposal: 541/2012 Compliance

A Proposal for a new Regulation on In-Vitro Diagnostic Medical Devices has been adopted by the European Commission on 26 September 2012 in the context of a broader revision of the regulatory framework for Medical Devices.

The proposal is currently undergoing the Ordinary Legislative Procedure. It has been adopted by the European Parliament on 2 April 2013 and shall now be discussed by the Council.

The main novelties proposed consist in:

  • Clearer and broader scope for the IVD legislation, in particular with regard to:
      • High-risk devices manufactured and used within a single health institution, which are subject to most of the requirements set out in the proposal;
      • Tests providing information about the predisposition to a medical condition or a disease (e.g. genetic tests) and tests providing information to predict treatment response or reactions (e.g. companion diagnostics), which are considered as in vitro diagnostic medical devices;
      • Medical software, which is explicitly mentioned in the definition of IVDs.


  • Clear definition and explicit identification of the respective tasks of the different Economic Operators (namely the manufacturer, the authorized representative, the importer and the distributor).


  • Stricter obligations for the manufacturer, which are proportionate to the risk class of the devices they produce. This implies – for example that:
      • All manufacturers should have a quality management system (QMS) in place to ensure that their products consistently meet the regulatory requirements;
      • QMS-related responsibilities are stricter for manufacturers of high-risk devices than for manufacturers of low-risk devices;
      • The Manufacturers is the sole responsible for the drawing up of the key-documents for the aimed at demonstrating the compliance with the legal requirements of each device placed on the market. These are the technical documentation and the EU declaration of conformity.


  • Specific provisions concerning product’s traceability consisting of:
      • A requirement that manufacturers fit their devices with a Unique Device Identification (UDI) which allows traceability;
      • A requirement that manufacturers/authorized representatives and importers shall register themselves and the devices they place on the EU market in a central European database;
      • An obligation for manufacturers of high-risk devices to make publicly available a summary of safety and performance with key elements of the supporting clinical data;
      • Further development of the European databank on medical devices (Eudamed),


  • Clear identification of the general requirements for clinical evidence for in vitro diagnostic medical devices which are proportionate to the risk class.
      • For the purpose of the Regulation ‘clinical evidence’ means the information that supports the scientific validity and performance for the use of a device as intended by the manufacturer
      • Manufacturer will always need to demonstrate the products’ conformity with the general safety and performance and the intended purpose of the device on the basis of clinical evidence.


 Moreover the proposed Regulation shall introduce some new concepts the field of IVDs:

  • Requirement for the manufacturers to have a qualified person within their organization. The ‘qualified person’ should be responsible for regulatory compliance;
  • Identification of clear conditions for the relabeling and/or repackaging IVDs.


Under the proposed Regulation the general obligations of the manufacturer shall consist in:

  • Ensure the product compliance with the relevant essential requirements;
  • Draw up the Technical Documentation, the Declaration of Conformity and the other documents aimed at demonstrating the product’s compliance with the EU legislation
  • Carry out the necessary conformity assessment procedures (that may vary in proportion with the level of risk of the concerned device).


Manufacturer established outside the European Union MUST appoint an European Authorized Representative.


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in In-Vitro Diagnostic Medical Device Directive