|April 2009||The current status you will find in our brochure. |
[ PDF 76 kB ]
The European Commission Service has published a new guidance document regarding the transitional period of the implementation of 2007/47/EC. This document provides additional information with regard to:
1. Compliance of medical devices with the new requirements
2. Evaluation by Notified Bodies according to new requirements
3. Certificates issued prior to the application of Directive 2007/47/EC
4. Consultation of authorities responsible for pharmaceuticals
5. Overlap with the Machinery Directive
Here you can download the new guidance document.
[ PDF 36 kB ]
You can also visit the Commisions' website to download all relevant documents.
|July 2009 |
Revision of a previous Statement issued in our Med-Info
Our Flyer "Transition to EU Directive 2007/47/EC" of April 2009 included the following statement:
Declaration of Conformity
All existing Declarations of Conformity will become invalid on
March 20, 2010. All CE-marked products placed on the market from March 21, 2010 will need to be covered by a new Declaration of Conformity. The Declaration of Conformity has to include a statement that the requirements of 2007/47/EC are fulfilled.
The above statement was the result of a Germany-wide discussion on how to interpret the new requirements.
In the meantime, the interpretation service of the European Commission has issued a new guidance document. This document points out that manufacturers must be able to prove their compliance with Directive 2007/47/EC. It does not require a new Declaration of Conformity to be issued.
Given this, as Notified Body we currently assume that generelly no new Declaration of Conformity including a reference to Directive 2007/47/EC needs to be issued.
Manufacturers, however, must very well be able to demonstrate compliance with the new medical devices requirements to external bodies, e.g. regulatory authorities. Proof can be furnished, inter alia, by one of the actions outlined below:
The manufacturer can furnish evidence that it has internally evaluated the new requirements and arrived at the conclusion that they are not applicable to the specific product.
The manufacturer can furnish evidence that it has internally evaluated the new requirements and arrived at the conclusion that they are complied with by the tests, assessments and analyses that have been carried out so far.
The manufacturer can furnish evidence that it has internally evaluated the new requirements and arrived at the conclusion that new tests, assessments and analyses are needed. These new tests, assessments and analyses must then be completed by the time at which the medical devices will again be placed on the market and/or put into service.
Disclaimer: This is a voluntary service provided by TÜV SÜD Product Service GmbH. While we analyse and interpret the relevant information very thoroughly, we accept no responsibility for the correctness of the information provided. Changes in the content of the interpretation on the part of the authorities are possible at any time.
Informative Road Show dealing with the new Directive starting in September
To encourage and inform you as our customer we are preparing the informative and highly applicable Road Show: "Regulatory framework of Medical Devices - Now and in the future" with high-calibre lecturers.
To obtain more information or to register please click here.
|August 2009 |
Effective from 21 March 2010, the new Directive 2007/47/EC will amend the two Directives 90/385/EC (active implantable medical devices) and Directive 93/42/EEC (medical devices).
The amended Directive 93/42/EEC now provides for extensive assessment of technical documentation.
NBOG document NBOG BPG 2009-4
[ PDF 34 kB ]was published on 10 July 2009. You, as manufacturer, and we, as Notified Body, now have the shared responsibility of classifying the medical devices in classes IIa and IIb into device groups. In this context, class IIa devices are subject to a different criterion from class IIb devices.
To estimate the impacts of these amendments and the number of technical documentations to be assessed during the audit, we need your support.
Please fill out the questionnaire [ PDF 226 kB ] for estimating the categorization of medical devices - online or offline - and then e-mail it to email@example.com or fax the document to us at 0049 89 5155 1202.
We would like to thank you very much for your support in this matter.
How to implement the Machinery Directive 2006/42/EC for medical devices
Almost all active medical devices are machinery as defined in the Machinery Directive.
Since the new MDD refers explicitly to the MD and the new MD no longer excludes medical devices, we must take a closer look at Article 3.
Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (*) shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex 1 to this Directive.
The keywords here are "more specific".
Interpretation by TÜV SÜD Product Service*
The essential requirements of the MDD (Annex I) describe the specific requirements to be fulfilled by a medical device.
This safety level is relevant and binding for the medical device, even if the MD specifies further requirements in the essential health and safety requirements set out in Annex I.
The requirements set forth in the MD are only applicable if the MDD has not addressed a requirement for a specific hazard.
The NB-MED document 'Machinery Directive's Essential Health and Safety Requirements (EHSR) relevant for Medical Devices' provides guidance as to which additional requirements are considered more specific and must therefore be addressed by a medical device. At present, the NB-MED document is only available as a draft document.
Application of the Machinery Directive
The new MD will come into effect in late 2009 without a transition period.
TÜV SÜD Product Service, ZLS and EK 9 agreed to issue a recommendation to their clients to use the Machinery Directive's EHSR in the conformity assessment process from now on to avoid major problems at the end of the year.
Recommended Action Steps
- Step 1: Assessment of the EHSR (Annex I of MD)
The manufacturer checks whether the "essential health and safety requirements" described in Annex I of the MD are applicable to their medical device. "More specific" must be read as "not addressed". The NB-MED-document provides assistance.
- Step 2: Integration as a design input
The manufacturer integrates the EHSR, as far as applicable (not addressed in Annex I of MDD), in addition to the essential requirements of the new MDD as design input for the medical device.
- Step 3: Integration into risk management
During the risk management process the manufacturer integrates all "more specific" (= not addressed in Annex I of the MDD) hazards, health and safety requirements of the new MD or documents either the required risk-reduction measures or the reason why a requirement is considered "not applicable".
- Step 4: "Harmonized Standards"
In the conformity assessment process the manufacturer checks whether harmonized standards that are "more specific" were published under the MD.
- Step 5: Documentation of the "essential requirements"
Similarly to the design input and the risk management process, all "additional requirements" will be added to the technical file. Reasons should be given for all essential health and safety requirements of the MD that are considered "not applicable".
- Step 6: Update of the declaration of conformity (DoC)
New DoC according to 93/42/EEC with cross-reference to the MD by 29 December 2009.
New DoC according to 2007/47/EEC with cross-reference to the MD by 21 March 2010.
The manufacturer must ensure that the new DoC and the product will reach the end user on time.
- Step 7: Update of the "technical file"
After steps 1-6 the manufacturer updates the technical file with all new documents.
* Disclaimer: This is a voluntary service provided by TÜV SÜD Product Service GmbH. While we analyse and interpret the relevant information very thoroughly, we accept no responsibility for the correctness of the information provided. Changes in the content of the interpretation on the part of the authorities are possible at any time.
|March 2010 |
New declarations of conformity required - yes or no?
In the April 2009 edition of our medical information flyer 'Transition to EC Directive 2007/47/EC', we informed you that we assumed, in view of the status of discussions at that time, that new declarations of conformity would have to be issued.
In our newsletter of 2 July 2009 we revised this statement and explained that not all declarations of conformity might have to be re-issued in general.
Subsequent discussions with several authorities and Notified Bodies revealed that the issue of new declarations of conformity has not yet been discussed clearly and uniformly across all EU Member States and that therefore the statements of the individual Member States on this subject also differ. While some EU Member States consider the issue of new declarations of conformity as unavoidable in general, other EU Member States consider internal evidence of compliance to be sufficient.
However, not only the European authorities, but other stakeholders too are interested in a declaration of conformity; they include hospital purchasing departments, registered practitioners and non-EU authorities.
Given this, we expect further discussions between authorities, manufacturers and Notified Bodies on the issue of new declarations of conformity. The cases in which no new declaration of conformity has been issued, may require increasing coordination and agreement between manufacturers and clients and/or authorities and/or suppliers or sub-contractors in the future.
In view of the fact that by 21 March 2010 many harmonized standards will lose their status as evidence of compliance with the essential requirements, we can only advise manufacturers at present to consider whether it may not be more sensible to issue a new declaration of conformity in order to keep all further discussions, phone conversations and correspondence to a minimum.
All declarations of conformity which are issued before 21 March 2010 and which are to document evidence of compliance with 2007/47/EC must include reference to 2007/47/EC. Such reference may be omitted in declarations of conformity issued after 21 March 2010, as Directive 2007/47/EC applies as a matter of principle and other options are no longer available.
Compliance with the essential requirements of the medical devices directive no longer ensured
Harmonized standards are published in the Official Journal of the European Union. Medical devices complying with the requirements of the standards listed in these publications may be assumed to comply with the essential requirements of the Medical Devices Directive.
Through this newsletter, we would like to draw your attention to the fact that many of these harmonized standards will become invalid by 21 March 2010 and will be replaced by new standards. Given this, these standards may no longer be used to assume compliance with the essential requirements of the Directive.
Please review the documentation of your medical devices to ensure that compliance with the essential requirements of the Medical Devices Directive is still maintained with the new editions of the harmonized standards. To continue to assume the compliance with the essential requirements of the Directive, revised or new requirements of these harmonized standards may have to be fulfilled.
The list of harmonized standards for general medical devices as per Directive 93/42/EEC can be found on the following web site:
The list of harmonized standards for active implantable medical devices as per Directive 90/385/EEC can be found on the following web site: