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How is Class I Medical Device Compliance Enforced?

Mark Meer

Trusted Information Resource
#1
I'm curious: how is Class I device compliance enforced?

Because NB is not involved, who (if anyone) would ever scrutinise a declaration of conformity or technical file?
Is it the responsibility of the competent authority under which the device is registered? Assuming no adverse events, are there any circumstances where compliance is surveilled (e.g. can a CA issue random audits of Class I manufacturers)?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi Mark,

There's a lot of info here: http://ec.europa.eu/growth/single-market/goods/building-blocks/market-surveillance/organisation_en

Unfortunately detailed reports seem to lag by a couple of years or so, and the level of detail (and enforcement, apparently) varies between Member States. In general, my impression is that enforcement is not fierce for medium or lower risk devices, and as always/everywhere the issue is available resources (in theory the system is supposed to be amazing...).

Cheers,
Ronen.
 

Mark Meer

Trusted Information Resource
#3
...my impression is that enforcement is not fierce for medium or lower risk devices...
I'm looking at the German surveillance program (as you say, outdated as of 2017), and it seems to imply that non-conformances are assessed for risk, and this drives customs officials' decision whether to suspend release of product entering the country. If this is correct, then would the following situation be possible?:
- Manufacturer found to be non-compliant to regulations
- Risk assessment determines risk of non-compliance to be minimal
- Customs officials, based on this assessment, continue to release product
- Business as usual for the manufacturer

From a safety and markets perspective I, in theory, would have no problem with this, I guess. If there is no risk, then why pursue enforcement? But from a regulatory-compliance standpoint, it seems odd that there'd be a path to continued non-compliance without punishment or other repercussions...

Do I have this completely wrong?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
... it seems to imply that ... If this is correct ...
Would this be possible? Who knows?... Too many unknowns and uncertainties.

But from a regulatory-compliance standpoint, it seems odd that there'd be a path to continued non-compliance without punishment or other repercussions...
I don't think anyone in the regulatory profession is naive enough to think that absolute 100% compliance exists, is possible or even necessary. That's the whole idea in risk-based regulation - where the consequences aren't grave there's more room for non-compliance. And it's rather probabilistic than binomial/deterministic - it's not guaranteed that one would get away with such a non-compliance, only more probable. Some might still get probed and there might be some repercussions. As with any random sampling regime.

Do I have this completely wrong?
Not completely...
 

rob73

looking for answers
#6
I can attest to the fact that the MHRA do audit files. I have on two occasions in the past had to send a copy of a technical file (Class 1 device) for review. Not that this has been repeated lately, the last time was about eight years ago.
 

Mark Meer

Trusted Information Resource
#7
I can attest to the fact that the MHRA do audit files. I have on two occasions in the past had to send a copy of a technical file (Class 1 device) for review. Not that this has been repeated lately, the last time was about eight years ago.
I'm curious what, in theory, would happen if there are concerns raised. For example, if it's noted that the manufacturer is declaring device conformity to a previously harmonized standard that is now obsolete (and no subsequent documentation was provided to show updated state-of-the-art safety). Could the ability to market be suspended/withdrawn? Would there be monetary punitive measures?
 

dgrainger

Trusted Information Resource
#8
Mark,
Generally MHRA will inform the manufacturer whats wrong and allow them to get into compliance - as per the regulators code.
But yes, MHRA have enforcement powers:

"...under the Consumer Protection Act 1987 include the following:
  • prohibition notices to ban the supply of any goods which are considered unsafe or do not comply with regulations;
  • notices to warn which requires a manufacturer to issue a warning at his own expense about any relevant goods, which are considered unsafe;
  • suspension notices to suspend the supply of any goods for up to six months, where it is suspected that a safety provision has been contravened;
  • forfeiture orders for goods where there has been a contravention of a safety provision;
  • notice to obtain information where MHRA requires a person to furnish information or to produce records to help decide whether to serve, vary or revoke a prohibition notice or a notice to warn."
 
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