How to Report Non-compliance and Corrective Action to EU Member States

[QAengineer13]

Hi all,

Need some guidance on how to report non-compliance and the corrective action taken to the member states in the EU.

Please help!

 

[Ronen E]

Hi all,

Need some guidance on how to report non-compliance and the corrective action taken to the member states in the EU.

Please help!

The MDD clauses that come to my mind only speak of your obligation to notify competent authorities when an adverse event has occurred or you have initiated a recall to prevent potetial adverse events. Is that the situation you were referring to?

Could you please state the MDD clause that raised your concern?

 

[QAengineer13]

The MDD clauses that come to my mind only speak of your obligation to notify competent authorities when an adverse event has occurred or you have initiated a recall to prevent potetial adverse events. Is that the situation you were referring to?

Could you please state the MDD clause that raised your concern?

Hi Ronen,

This is in reference to ROHS directive (2011/65/EU), I have found the list of competent authority http://ec.europa.eu/growth/sectors/medical-devices/contacts_en . Hope this is yet...it is little confusing because if you read the Blue Guide for EU rule it refers to the

PROSAFE “Guidelines for Businesses to manage Product Recalls & Other Corrective Actions”278 have been designed to assist businesses to ensure, whenever necessary, the appropriate corrective actions and follow-up once a product has been already made available on the EU market or is coming from third countries.

Also found ROHS member state contact information, so I was puzzled ...who to contact...at the moment thinking abt sticking to the Contacts in European Commission. Any inputs?

 

[Ronen E]

I see, you refer to 2011/65/EU (RoHS recast) Article 7 (i):

manufacturers who consider or have reason to believe that EEE which they have placed on the market is not in conformity with this Directive immediately take the necessary corrective measures to bring that EEE into conformity, to withdraw it or recall it, if appropriate, and immediately inform the competent national authorities of the Member States in which they made the EEE available to that effect, giving details, in particular, of the non- compliance and of any corrective measures taken;

Perhaps this will help.

 

[Ronen E]

Same context, a little more recent:

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013PC0078&from=EN

 

[shimonv]

Also found ROHS member state contact information, so I was puzzled ...who to contact...at the moment thinking abt sticking to the Contacts in European Commission. Any inputs?

Since RoHS is not specific to medical devices and it has its own directive it would make more sense to contact the RoHS member state contact persons; less confusion this way.

Shimon