Relation between 93/42/EEC and 2007/47/EC

[Cinti]

Hi,
Everyone may aware that the MDD has updated and it will become mandatory from March 2010. I need one help. In which means we have to highlight that we updated documents in line with amendments mentioned in 2007/47/EC.

Shall we mention MDD 93/42/EEC + 2007/47/EC or we have to mention only 2007/47/EC in all documention like Doc, technical file etc., How notified body mention this reference in new certificate? Do anybody have idea? Kindly share.

2007/47/EC is the amendment only and it is not replacing MDD 93/42/EEC. Is it correct?

Thank you

regards
Usha

 

[DannyK]

Mention it as 93/42/EEC M5 within your documents such as Declaration of Conformity.

Be sure to update your Essential Requirements list.

 

[bio_subbu]

Hi,
Everyone may aware that the MDD has updated and it will become mandatory from March 2010. I need one help. In which means we have to highlight that we updated documents in line with amendments mentioned in 2007/47/EC.

Shall we mention MDD 93/42/EEC + 2007/47/EC or we have to mention only 2007/47/EC in all documention like Doc, technical file etc., How notified body mention this reference in new certificate? Do anybody have idea? Kindly share.

2007/47/EC is the amendment only and it is not replacing MDD 93/42/EEC. Is it correct?

Thank you

regards
Usha

Dear Usha

In relation to Medical Devices, the European Community has adopted the Directives including 90/385/EEC (AIMDD), 93/42/EEC (MDD), 98/79/EC (IVDD), and 2007/47/EC amendment of 90/385/EEC and 93/42/EC.

The amendments to the MDD has been published a number of additional directives amending the original directive has been introduced , the recent revising directive 2007/47 EC is amending of the Directive 90/385/EEC concerning active implantable medical devices, Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market following a review of the existing provisions by the European Commission and member states but the Directive 2007/47/EC will come fully into force until 21 March 2010.

Be clear that 2007/EC only for amendment not for replacing MDD 93/42/EEC. I don’t think so to mention the revision details in all the documents. But should mention the essential requirement check list Annex-I and make sure whether you met the recent amendment as required by Directive 2007/47EEC - OJ L247/ 21.9.07

Thanks and Regards
S. Subramaniam

 

[yana prus]

Hi Usha

This link can be helpful - it is a recent EC guidance on the implementation of 2007/47/EC.
http://www.emergogroup.com/files/2007-47-EC-guidance.pdf

"Manufacturers are required to declare the conformity of their product with the applicable directive in form of a Declaration of Conformity. If manufacturers place products on the market or put them into service which comply with the new requirements prior to 21 March 2010, they should document that their Declaration of Conformity states compliance with Directives 90/385/EEC or 93/42/EEC, respectively, as amended by Directive 2007/47/EC. Declarations of Conformity issued as of 21 March 2010 are automatically deemed to refer to the relevant directive in its revised version."​

Para. 3 discusses the status of certificates issued prior to the application of Directive 2007/47/EC.​

Best,​

Yana​

 

[bio_subbu]

In addition to above, to implement the requirements of Directive 2007/47/EC in your company, you should proceed as a gap analysis has to be performed for processes and products with regard to the requirements of Directive 2007/47/EC. The product requirements have to be reviewed in due time, including design changes, review/ revisions of instructions for use and of labels, retests, re-verification of the essential requirements in particular of clinical evaluations, review of classification, consultation procedures (in particular for active implantable medical devices with a drug component)

The Notified Body will audit for your facility in compliance with the requirements of Directive 2007/47/EC in subsequent surveillance and recertification audits. For further details contact your notified body.

Hi Yana,

Thanks for sharing the guidance document “IMPLEMENTATION OF DIRECTIVE 2007/47/EC AMENDING DIRECTIVES 90/385/EEC, 93/42/EEC AND 98/8/EC”

Thanks and Regards
S. Subramaniam

 

[Removed by request]

When writing up the new manufacturer's Declaration of Conformity (per the amended 2007/47/EC) how should the MDD be referenced?

1. "Medical Device Directive: Council Directive 93/42/EEC, as amended by Directive 2007/47/EC";

2. "Medical Device Directive: Council Directive 2007/47/EC"; or

3. others????

thanks

 

[SteveK]

When writing up the new manufacturer's Declaration of Conformity (per the amended 2007/47/EC) how should the MDD be referenced?

1. "Medical Device Directive: Council Directive 93/42/EEC, as amended by Directive 2007/47/EC";

2. "Medical Device Directive: Council Directive 2007/47/EC"; or

3. others????

thanks

Geechj,

As indicated, just reference 93/42/EEC. If you are audited by a NB to the Medical Device Directive, your certification will only reference this (primary) directive.

Steve

 

[sokku]

Mention it as 93/42/EEC M5 within your documents such as Declaration of Conformity.

Be sure to update your Essential Requirements list.

What are the main changes in Annex I Essential requirements in accordance with amendment 2007/47/EEC

 

[SteveK]

What are the main changes in Annex I Essential requirements in accordance with amendment 2007/47/EEC

Other than downloading a copy of the updated 93/42/EEC try:

http://www.intertek-etlsemko.com/po...ROD_PG/Manufacturers_Guide_to_Revised_MDD.pdf

 

[bio_subbu]

What are the main changes in Annex I Essential requirements in accordance with amendment 2007/47/EEC

Hi

Find below amended details of Annex I – Essential Requirements as per amendment Directive 2007/47 EEC

1. Point 1 added: ergonomic features of the design, the level of training and knowledge of the user when performing the risk analysis

2. Point 6a added: clinical evaluation for all devices required according Annex X (in consequence: Point 14 deleted)

3. Point 7.4 ("integrated medicinals") slightly changed

4. Notified Body must verify usefulness of substance (medicinal, blood derivative) and NB to seek a scientific opinion from one of the NCAs or EMEA

5. Changes in manufacturing process have to be reported by manufacturer (NB (NCA involved in initial assessment

6. Point 7.5 ("substances leaking from device") replaced and extended by substances that
are carcinogenic, mutagenic, or toxic to reproduction (CMR)

In specific: for phthalates

Category 1 or 2 (according Directive 67/548/EEC) identification on labeling required

For devices intended for treatment of children, pregnant women, or nursing mothers a specific justification" for phthalates' required plus information on residual risks and precautionary measures in the labeling

7. Point 12.1a added (software):
Software (stand-alone or incorporated) to be validated "according to the state of the art taking into account the principles of development life cycle, risk management, validation, and verification"

8. Point 13 amended: labeling

9. Point 13.3 (a): name and address of authorized representative must be included on the label

10. Point 13.3 (f) replaced by the requirement for single-use devices to be marked, and for such a marking to be consistent across the EU

11. Point 13.6 (o): details of any human blood derivatives in a device to be included in the IFU in addition to the details of any medicinal substances

12. Point 13.6 (q) (added): IFU to include date of issue or revision reference.

Thanks and Regards
S. Subramaniam