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  Post Number #1  
Old 7th June 2005, 03:04 PM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,692
Read This! Proposed Revision to the Medical Device Directive Medical Devices Directive 93/42/EEC

Proposed Revision to the Medical Device Directive

Last edited by Marc; 16th August 2017 at 03:59 PM. Reason: Dead link removed.

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  Post Number #2  
Old 7th June 2005, 04:18 PM
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Marc

 
 
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Some background from the above link:
Quote:
Invitation for Public Comment

In line with the Communication EnglishPDF format 281KB presented to the Council and Parliament in the summer of 2003 the Commission services, together with stakeholders, has prepared an early draft text to amend the Medical Devices Directive 93/42/EEC.

This text is now available for public comment.

For this purpose we attach a text highlighting the changes EnglishPDF format 356 KB as they would appear in the current text of Directive 93/42/EEC.

Comments should be submitted via e-mail : to submit your comment, please click here.
The period for consultation will remain open until 6 weeks from publication on the web site. Closing date: 25/06/2005.

The consultation is subject to data privacy rules. A privacy policy statement EnglishPDF format 21 KB specifies how your data will be used.

Background

There are three Directives on Medical Devices:

* Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (AIMD);
* Directive 93/42/EEC concerning medical devices (MDD); and
* Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)

In June 2002, the Commission’s Medical Device Experts Group (MDEG) which is made up of National Authorities, Notified Bodies, Industry and Standards Bodies produced a Report EnglishPDF format 320 KB on the functioning of the Directives on Medical Devices. This Report contains a detailed analysis of experience gained in their implementation since 1990.

The Report came to the conclusion that, whilst overall the experience has been extremely positive, some improvement could still be made.

Whilst most of these improvements could be made without legislation it was concluded that there was a need to modify some of the provisions to be found in the Medical Devices Directive.

The conclusions of the Report were communicated to the Council and Parliament. Both institutions endorsed the recommendations made.

The most important areas of amendment concern conformity assessment, including the designation and monitoring of notified bodies, clarification of the clinical evaluation requirements and post market surveillance. Provisions are also made to increase transparency and an instrument was also considered necessary to make binding decisions when there are conflicting national interpretations.

The text of the Draft Extended Impact Assessment EnglishPDF format 64 KB relating to the proposed amendment to the Medical Devices Directive 93/42/EEC is also available.



The principal proposed amendments

Conformity assessment modules

Text has been developed to further clarify that according to Annexes II, IV, V and VI notified bodies are required, to assess the design documentation for a selection of the devices being manufactured as part of their assessment of the quality system,. This selection should be done on a representative sample of the devices concerned.

Clinical data and evaluation

Significant changes are proposed to Annex X to clarify the requirements for clinical data and its evaluation.

This proposal has also resulted in additional and modified references to clinical data, including the definition of clinical evaluation as well as providing for the possibility to centralise data on clinical investigations in the European databank.

Legal certainty regarding scope

To ensure coherent implementation of the Directive, it has been proposed to add to Article 13, a method (based on comitology) to allow the Commission to make binding decisions as to whether or not a product classifies as a medical device.

In order to clarify that it is possible for both the Directive on medical devices and the Directive on personal protective equipment to simultaneously apply to a product, such as a surgical glove, the reference in Article 1 to the Directive on personal protective equipment will be deleted.

Measures to increase transparency (e.g. relating to the CE Marking of high risk devices)

Article 20 on confidentiality, which currently maintains that all information available under the Directive is confidential, will be amended to allow certain information to be made public.

Legal basis for better coordination and communication of market surveillance activities

The market for medical devices is a global market, with a significant number of devices being imported into the EU. This has led to an increasing need to coordinate the activities of national authorities, particularly where one national authority takes action under the Directive that affects other Member States and/or non EU territories.

This type of coordination is particularly important when taking necessary market surveillance measures to protect public health, such as the restriction or removal of non-conforming devices from the market.

Thus, a new provision Article 20b will be added to provide a legal basis for these coordination and international activities.

Clarification regarding drug/device provisions

The provisions dealing with the conformity assessment of devices that incorporate a medicine or stable derivates of human blood or human plasma as an integral part (Annex I Section 7.4) require amendment to reflect past experience. This will lead to a clarification of the roles of the notified body and the relevant authority.

Amendment of other Directives:

AIMD - Alignment of text across all three medical device directives, AIMD, MDD & IVDD.

The AIMD, adopted in 1990, was the first in the series of Directives on medical devices. It has not been amended since that time unlike the two other directives - the MDD and the IVDD.

To ensure consistency and to update the AIMD in terms of health protection measures, certain aspects such as authorised representative, the European Databank, health protection measures, and the application of the Directive 2000/70/EC on medical devices incorporating stable derivates of human blood or human plasma are to be added to the AIMD. This latter will require the introduction of a large amount of text.


Directive 98/8/EC concerning the placing of biocidal products on the market

The Directive on biocides will be modified to clarify that in vitro diagnostic medical devices, which are now the subject of a specific Directive, are to be excluded from the scope of the biocides Directive.
Thanks to Marc for your informative Post and/or Attachment!
  Post Number #3  
Old 6th November 2007, 01:00 PM
km214

 
 
Total Posts: n/a
re: Proposed Revision to the Medical Device Directive Medical Devices Directive 93/42/EEC

Hello Marc and forum,
I am presently in a QM contract role and have been reviewing and performing a GAP of the MDD against internal docs. I found that 2007/47/EC (the newest revisions to the MDD) implements several changes to those initiated in the 98/79/EC. Has anyone compiled a list of all these amendments to the 93/42/EEC-my starting point for the MDD? I will after I complete my GAP formulate a list of the changes implemented by each revision and post it here. I have found several instances where the information shared in this forum has saved me immense amounts of time and effort. I appreciate the existence of this forum and all the knowledgable people sharing info here.
THANK YOU
Katherine McKay
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