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Archive: News and Views 2006 January


Content:
  • Review of 2005
  • Update of the Medical Devices Directives
  • Timeline and process of the update
  • Clinical Evaluation of Medical Devices
  • Cleaning and Sterilisation of Reusable Instruments
  • Changes to the MDSS Website

Review of 2005

MDSS can look back at a successful and to an eventful business year.  A considerable number of new clients “appointed” MDSS as their authorized representative.  As a result, the number of incidents reported by MDSS to the various European Competent authorities, on behalf of our clients, increased as well.  Nevertheless, all events were resolved or are being resolved to the satisfaction of all parties concerned.  The increased event number is simply due to the increased number of clients.  However, an overall trend is noticed by the various competent authorities as well.  The authorities do not question the safety of products at this point.  It is simply concluded that the vigilance system is now working as intended.  In particular, the UK noticed a significant increase of reports a while back with the promotion of incident reporting by the user, patient or others which is already implemented in other countries.  Enclosed is a link to the German statistic.  It shows impressively the trend over the past five years. http://www.bfarm.de/de/Medizinprodukte/vigilanz/FallzahlentwAktuell.pdf

In addition the workload for MDSS increased because the Competent Authorities’ activity in terms of market surveillance is greater than before (!).  I would like to illustrate this by the following example. 

When the Medical Device Directive came into force, the vigilance system was new for the Competent Authorities as well.  In the early days, a recall was considered an appropriate means for a corrective action and an incident was “happily” closed by the Competent Authority.  Today, the vigilance goes further with monitoring the recall activities.  Therefore, any recall should be handled in close connection with the involved Competent Authorities.   Closure should be reached with informing the authorities of the recall success relevant to the particular country.

Update of the Medical Devices Directive

Another important event in 2005 was the publication of the Commission proposal just before Christmas updating the Medical Devices Directives.  We would recommend starting the review process of the proposed changes to the Medical Device Directives in order to be prepared for the final document.  There are significant changes in particular regarding the classification of Medical Devices and its related conformity assessment.  Changes affect the design documentation and design review.  Clarification has been given in the clinical evaluation area and the compliance of custom made devices.  Last, but not least, the post market surveillance has been updated as well.  In addition, the goal was to align all three Medical Device Directives -the Active Implantable Medical Devices Directive 90/385/EEC, the general Medical Devices Directive 90/42/EEC and the In Vitro Diagnostic Medical Devices Directive 98//79/EC.  Enclosed is the link to the CURRENT revisions.  http://europa.eu.int/comm/enterprise/medical_devices/legislation_en.htm .

We recommend downloading them for your internal quality records since they include the previous corrections and amendments.  Most importantly it reflects the status of the legislation before the new upcoming major revision in a consolidated version.  The consolidated text incorporates changes in the original text.  It is simply a better reading. Please note that it does not reflect the new update!

Timeline and process of the update

The update process started a while ago.  The directive actually includes in one of its articles that a review shall be conducted after 5 years.  In 2003 this review started with a report on the functionality of the Medical Devices Directive to the parliament. http://europa.eu.int/comm/enterprise/medical_devices/consult_docs/com2003.pdf 


After that a lot of the discussions took place at the Medical Device Expert Group.  This group consists of stakeholders from the competent authorities, the industry associations and as well the commission.  In the middle of 2005, a public consultation took place on the European Website (see News and Views May 2005).  Quite a few responses were received and a summary of the responses to the consultation can be found on the EU website. http://europa.eu.int/comm/enterprise/medical_devices/consult.htm


The public consultation was closed on June 25, 2005.  From that day on the proposal was expected to be released at any time.  The proposal was finally published on the EU website a few days before Christmas. http://europa.eu.int/comm/enterprise/medical_devices/revision_docs/dgentr-pe-f3-32131-pe-md_en.pdf


An interesting reading is the impact assessment provided by the commission: http://europa.eu.int/comm/enterprise/medical_devices/revision_docs/entr_pe_dts_ia_md.pdf


At this point, I just want to note one aspect which I find very interesting.  It was very much anticipated that re-usable surgical instruments will be reclassified to risk class IIa.  This change has not been introduced in this proposal due to the input during the consultation process. 

As already noted we recommend starting the review of the complete proposal to evaluate any impact on your quality system and/or product conformity.  For higher risk class products the involvement of your Notified Body early on may be beneficial.  The anticipated transition period for the implementation will not be as long as it was with the initial implementation of the directive.  You may certainly involve MDSS in such a specific assessment.  Please contact us for additional information.

It is expected that this proposal will go through the European Parliament without many obstacles.  Certainly changes may still be introduced and if so mainly on the European Parliamentary level. 

Clinical Evaluation of Medical Devices

I would also like to make our clients aware of some new additions and changes of the interpretation of the directive which will be fostered with the new directive proposal. 

MDSS was hired to guide a German client –a manufacturer of risk class I products through a Competent Authority inspection.  After a full day of inspection at the manufacturer’s site, only a few minor aspects were noted.  However, in the end the inspector noted that no clinical evaluation reports are available for the products which became a main subject for him.  He referred to the guideline Evaluation of clinical Data MEDDEV 2.7.1(http://europa.eu.int/comm/enterprise/medical_devices/meddev/2_7.pdf ) and insisted on a clinical evaluation.  This was much of a surprise considering the low risk class of products reviewed (toilet chair for handicapped persons -:).

Today, it seems to be commonly understood among Competent Authorities that clinical proof shall be held by the manufacturer for all risk classes of products including risk class I products.  This does not mean that clinical trials have to be conducted but clinical documentation e.g. literature review should be readily available at the manufacturer’s site in the technical documentation. 

On a different occasion, MDSS was part of an Authority’s investigation of one of its clients and again the clinical documentation was questioned.  The data provided were issued when the devices were CE marked for the first time in 1998.  The inspector noted that these data are not sufficient to support the product any longer.  He did not indicate that the data were not valid anymore but a thorough review should take place to evaluate whether in the meantime any new data have become available.  Any new data should be evaluated by the manufacturer to ensure the compliance and state of the art of the product.  The notified body confirmed the deviation.

The current interpretation leads to the conclusion that clinical data must be established as well for low risk class products and as well should be updated on a regular basis e.g. via a quality system according to EN ISO 13485 or simply GMP).  You may certainly involve MDSS in such a specific clinical evaluation assessment –establishing and/or updating.  Please contact us for an additional information.

Information concerning the cleaning and disinfection of reusable instruments

During the last year, inspections were done on manufacturers of reusable surgical instruments in Germany.  In the MDD Annex I section 13.6 (h) essential requirements are stipulated for the instruction of reusable instruments concerning the appropriate process to allow the reuse of such products.  Nevertheless, in the past no standard was available for the compliance of that particular aspect.  Today, the standard EN ISO 17664 is available and should be taken into consideration when stipulating those aspects in the instructions for use.  Clear statements in the instructions must be provided.  MDSS recommends verifying that the standard is being followed. 

The latest feedback we received from one client was that it was considered a deviation during the surveillance assessment conducted by its notified body.  Please note that the standard applied for your products should be reviewed on a regular basis.  A list of European Standards can be found on the EU website which today is quite reliable and kept up to date. For the MDD: http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html

For the IVD  http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/invimedd.html

For the AIMDD http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/implmedd.html


Changes to the MDSS Website

Certain parts on the MDSS website will only be accessible to our clients.  There are various reasons for restricting the access.  The main aspect is that you, our clients enable us to provide the information on the website and therefore should have prominent access.  In addition it will be used to provide detailed information on all related aspects regarding our service and you will find in the future the various MDSS forms and procedures relevant to our clients.  

The Login name is:  MDSSclient

The password is:   password

As long no specific client related information is being stored on the website, no personnel log in is required.  The password access will change regularly.  We will keep you updated.   

I would like to take this opportunity to thank you for the trust that you have placed in us.  MDSS wishes you a Happy and Successful New Year.  May your European business continue to prosper.   

As always if you have any questions or would like to have further clarification, do not hesitate to contact us.

Ludger Moeller
President
MDSS

 

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