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Archive: News and Views December 2009 II

Dear valued Client,

Please take the time to read this entire email.  The information provided within is relevant for both manufacturers of medical device  and in vitro diagnostic medical devices.  IVD manufacturers please also note the change to the German legislation regarding HIV tests.

In 2007 Directive 2007/47/EC was published which amends  Directive 90/385/EEC  for Active implantable Medical Devices, Directive 93/42/EEC for Medical Devices and Directive 98/8/EC  for Biocide Products.

We would like to remind you once again that the 2007 amendment to the Medical Device Directive 93/42/EEC (MDD) comes into force in March 2010.  If  your company is a manufacturer of medical devices  within the meaning of the MDD, you need to immediately identify the new requirements and implement necessary actions by March.  Attached is a consolidated version of the MDD which includes the revisions of 2007 (M5).

An  amendment to the Biocidal Directive excludes IVD medical devices  from the scope of the Biocidal Directive.  The amendments of the Medical Device Directive are not applicable  to IVD medical devices.

Of the several amendments to the MDD, one is particularly significant for the medical device CE technical file   Please be advised all medical devices, regardless of the its classification, must have a clinical evaluation report (assessment and analysis of clinical data) in its technical file.

Clinical data means 'the safety and/or performance information that is generated from the use of a device.   Clinical data are sourced from:

  • clinical investigation(s) of the device concerned; or
  • clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
  • published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

The MEDDEV 2.7.1 Guidance on Medical Devices: Evaluation of Clinical Data provides guidance for manufacturers and notified bodies and should be taken into consideration when establishing clinical data.

Currently, the following harmonized standards are applicable to medical device clinical investigations.


EN ISO 14155-1:2003 - Clinical investigation of medical devices for human subjects -  Part 1, General requirements

EN ISO 14155-2:2003 - Clinical investigation of medical devices for human subjects – Part 2, Clinical investigation plans.


(Versions 2009 were  recently published in November and the citation in the Official Journal of the European Commission is expected).

A draft  standard ISO /DIS 14155:2009 - Clinical investigations of medical devices in human subjects - good clinical practices is also now  available.  The draft revises and combines the 2 above  mentioned standards.  The European draft prEN ISO 14155 is also under approval with CEN  (European Committee for Standardization).  With a positive result it would be published as a EN standard (European Harmonized Standard).


The  Medical Device Directive does NOT apply to IVD medical devices.  (See  MDD article 1, section 5).  Consequently, the clinical evaluation report is not a requirement for the IVD CE technical file.  However, the IVD Directive 98/79/EC does have performance evaluation requirements which must be reflected in the IVD technical file.

A performance evaluation is an investigation of the performance of an IVD based upon data already available, scientific literature and / or performance evaluations studies.  A device for performance evaluation’ means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises.


The IVD CE technical file must include adequate performance evaluation data showing the performances claimed by the manufacturer and supported by a reference measurement system (when available).  Information on the reference methods, the reference materials, the known reference values, the accuracy and measurement units used must be included.  Such data should originate from studies in a clinical or other appropriate environment or result from relevant biographical references.   (See IVDD, aticle 1.2.d - Annex I, part A, section 3 – Annex III, section  3 & Annex VIII.)


Currently, the following harmonized standard is applicable to IVD medical device performance evaluations.

EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices.


Please be aware that provisions regulating clinical investigations can become applicable if a performance evaluation involves:

  1. Invasive sampling is conducted either exclusively or supplementary to obtain a specimen for the purpose of a performance evaluation of an in vitro diagnostic medical device,
  2. In the context of the performance evaluation study, additional invasive or other stressful examinations are conducted,
  3. The results obtained in the context of the performance evaluation are to be used for diagnostic purposes without it being possible to confirm them by means of established procedures. 


In the remaining cases, the consent of the person from whom the specimen is to be taken, is necessary in so far as this person’s personal rights or commercial interests are affected.

In March 2010 the amendments of 2007 should be transposed into each member state national legislation.   As already noted in the past, member states may take the opportunity to implement additional requirements.  For example, the German Medical Device Act will be amended  as follows:

IVD medical devices for the determination of HIV may only be delivered (handed) to:

  1. physicians
  2. ambulant and in patient health care facilities, wholesale, apothecary
  3. Health authorities the Federal, state, township & township organizations.

We hope the above information is of assistance.  Please do not hesitate to contact us if you have any questions.

Best regards,

Your MDSS Team