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

[bio_subbu]

In addition to above, Annex I-Essential Requirement checklist is interpreted by another participant as per amended directive 2007/47/EEC refer this thread

 

[sokku]

Hi Stevek and Bio Subbu

Thanks for the excellent information and link, I very much interested to know the summary of changes in other topics like clinical data, software, post market surveillance and etc…

 

[yana prus]

Hi Stevek and Bio Subbu

Thanks for the excellent information and link, I very much interested to know the summary of changes in other topics like clinical data,

link to a presentation "Clinical Implications of the revised MDD"

(broken link removed)

 

[bio_subbu]

Hi Stevek and Bio Subbu

Thanks for the excellent information and link, I very much interested to know the summary of changes in other topics like clinical data, software, post market surveillance and etc…

The changes are in the following main topics

Clinical data and evaluation

Clarification and increased requirements on provisions on clinical evaluation and clinical investigations (Annex X)

Medical Purpose

In order to clarify that only products which have a medical purpose come within the scope of the Directive a proposed amendment is made to the definition of a medical device.

Post Market Surveillance

Post Market Surveillance including vigilance is strongly emphasized in the new Directive. This immediate action is also triggered by the new European MEDDEV 2.12-1 Rev 5 guideline on vigilance.

New provision, Article 20a: provides a legal basis for the co-ordination and international surveillance activities.

Software

"Software" has been specifically introduced in the definition of medical device and new requirements have been set for the development of software identified as medical device (risk management, verification, validation)

Measures to increase transparency

Confidentiality requirements (Article 20) have been relaxed allowing certain information on all devices to be made available, such as summary information on the approval of high risk devices.

Clarification regarding medicinal products / medical device provisions

Provisions currently contained in Annex-I Section 7.4 of the Directive are modified to clarify both the role of Notified Bodies and the national authorities for medicines or the European Medicines Agency (EMEA).

Devices with an ancillary human tissue engineered product

Additional provisions for devices with an ancillary human tissue engineered product within the scope of the Directive.

Custom-made devices

Change affects custom made device manufacturers to set up a post market vigilance system of reporting to authorities, as already in place for other devices. In addition a requirement is introduced that the 'Statement' under Annex VIII should be also given to the named patient for whom the device has been manufactured and that it must contain the name of the manufacturer.

Regards
S. Subramaniam

 

[sokku]

Thank you so much guys, sharing such a nice & detailed information with respect to 2007/47/EEC Directive.

 

[Medsearch]

Does anyone have history of MDD amendment details including amendment directives and published date?

 

[bio_subbu]

Does anyone have history of MDD amendment details including amendment directives and published date?

MDD has been published a number of additional Directives amending the original Directive. Please find below the history of amendments and details of additional directives and year of publishing. Normally these amendments are being published in official journal of European communities.

1). 2000/70/EC Amending Council Directive 93/42/EEC as Regards Medical Devices Incorporating Stable Derivates of Human Blood or Human Plasma. Directive of the European Parliament and of the Council

Directive 2000/70/EC (OJ L313, 13.12.2000)

2). 2001/104/EC Amending Council Directive 93/42/EEC Concerning Medical Devices. European Parliament and Council Directive

Directive 2001/104/EC (OJ L6/50, 10.01.2002): these directives brought devices incorporating stable derivatives of human blood or human plasma under the scope of the MDD

3). 2003/12/EC Reclassification of Breast Implants in the Framework of Directive 93/42/EEC Concerning Medical Devices. Commission Directive

Directive 2003/12/EC (OJ L082, 4.2.2003): reclassification of breast implants into Class III

4). 2003/32/EC Introducing Detailed Specifications as Regards the Requirements laid down in Council Directive 93/42/EEC with Respect to Medical Devices Manufactured Utilising Tissues of Animal Origin. Commission Directive

Directive 2003/32/EC (OJ L105/18, 26.4.2003): covers specifications in relation to risks of transmitting transmissible spongiform encephalopathy (TSE) under normal conditions of use to patients or others, via medical devices manufactured utilizing animal tissue which is rendered non-variable or non-viable products derived from animal tissue

5). 2005/50/EC Reclassification of Hip, Knee and Shoulder Joint Replacements in the Framework of Council Directive 93/42/EEC Concerning Medical Devices. Commission Directive

Directive 2005/50/EC (OJ L210, 12.08.2005): Reclassification of hip, knee and shoulder joint replacements

6). 2007/47/EC: amendment 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; Directive 2007/47/EC will come fully into force until 21 March 2010.

Hope you will find useful and informative.

Regards
S. Subramaniam

 

[Removed by request]

thanks for the information in response to proper referencing of the MDD. I've been in recent conversation with our auditor/Notified Body and he claims it should just be referenced as "2007/47/EC". Is there an official document that I could rely on for what it is actually supposed to be referenced as? I'd like to only have to update our documents (procedures, quality manual, ER checklists, and Dec of Conformities) one time for this reference change.

Thank you.

 

[bio_subbu]

thanks for the information in response to proper referencing of the MDD. I've been in recent conversation with our auditor/Notified Body and he claims it should just be referenced as "2007/47/EC". Is there an official document that I could rely on for what it is actually supposed to be referenced as? I'd like to only have to update our documents (procedures, quality manual, ER checklists, and Dec of Conformities) one time for this reference change.

Thank you.

In my knowledge, there is no official document released so for and I don’t think so to do reference as 2007/47 EEC. Just reference 93/42 EEC in your declaration of conformity and ER checklist as stated by Steve in previous reply. But during your surveillance audit you have to show them objective evidence that meeting all the requirements in accordance with amended directive 2007/47 EEC.

 

[Cinti]

Dear Subbramanian,

Thank you very much for your immediately and timely reply. I am afraid while seeing Geechj post because i already updated all my documents as " MDD 93/42/EEC as amended by directive 2007/47/EC of 21 september 2007".