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Who polices/surveils Class I Medical Devices in the EU?

Mark Meer

Trusted Information Resource
#1
Curious: what surveillance mechanisms exists for the conformity of Class I devices in the EU?

Unlike other classes of device, Class I devices have self-declared ER conformity, and can CE-mark without the involvement of a notified body (NB).

Given that there is no NB involved, does this mean no surveillance audits? If so, how is ER conformity of Class I devices policed?

I presume that any reportable events, advisory notices, recalls, etc. may trigger surveillance. But absent any such device issues, can a manufacturer of Class I devices expect any sort of surveillance/audits with respect to their self-declared CE-marked Class I devices?

MM.
 
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paulag

Involved In Discussions
#3
§ 26 of German Medical Devices Act states that all medical devices (manufacturers) are subject to national authority surveillance, regardless of classification. Before placing a medical device on the German market, you have to inform the local authority about the device, the contact Person, etc.... even with simple class I devices
 
#4
Each member state of the EU, and states that are part of EFTA (and Turkey), have a designated authority known as the Competent Authority (CA).

The list of CAs is here:

https://ec.europa.eu/docsroom/documents/19262/attachments/1/translations/en/renditions/native

In addition to being the countries 'regulator' and place of device registration, the CA authorises 'Clinical Investigations' and also supervises, audits and authorises Notified Bodies within it's state.
 

Mark Meer

Trusted Information Resource
#5
Thank you for all the replies. ...but I'm unfortunately still unclear.

To clarify: I'm curious about the systems in place for ACTIVELY surveiling Class I manufacturers.

As I say, in any other class, manufacturers are subject to annual audits, and unannounced audits by NBs. With Class I, however, is there any schedule of inspections/audits?

The MHRA link that dgrainger posted only says they have the right to conduct inspections, but it sounds like these are in "for cause" cases...

Can Class I manufacturers expect any kind of action (inspections/audits) absent any "for cause" issues?
 

pkost

Trusted Information Resource
#7
As Ronen said, in short, there is typically no scheduled audits/inspections. Remember that these are low risk devices, therefore why prioritise their inspection?

That being said, there are some country specific exceptions Turkey for one will inspect Class I technical files, I believe Spain may inspect sites of medical device manufacturers (this is by no means a definitive list)
 
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