Medical Device which is both Class I & CAT III PPE

N

nurhakim

#1
Hi,

Is it possible that ONE product can be classified as a Class I (non-sterile, non-measuring) under 93/42/EEC and CAT III under 89/686/EEC at the same time? If a manufacturer already have a Class I product and self declare it, and later on wants to claim the same product as CAT III (PPE) without having a CE Mark certification, is it permissible?

Thanks.
 
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N

nurhakim

#2
Re: Class I medical device & CAT III PPE

By the 2007/47/EC which came into full force as of March 21st 2010, face masks may have to comply from with the essential safety requirements of the MDD 93/42/EEC as Class I medical devices AND also with the essential safety requirements of the PPE 89/686/EEC.

The EU Commission “categorization guide” on PPE 89/686/EEC specified in its explanation of category 7.3. that “surgical masks” were excluded of the scope of the PPE 89/686/EEC but added as a footnote (3):
“Where such masks are intended to protect the wearer against microbial and viral infections, etc. they are in certification category III (personal protection rather than medical use).

The MDD 93/42/EEC as amended by the 2007/47/EC is stating now in its article 1,6.. “Where a device is intended by the manufacturer to be used in accordance with both the provisions on Personal Protective Equipment in Council Directive 89/686/EEC (1) and this directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.”

For instance, surgical masks being used for patient protection (MDD Class I) and protection of the practitioner using them (PPE category III) and risking infection from the patient during intervention.

For surgical masks that have no particular claim like a protection of the wearer against infectious diseases such as HIV contaminated blood or viruses (coming from the patient, in that case the mask will become a PPE category III), the surgical mask will have only to comply with MDD 93/42/EEC as amended by the 2007/47/EC under the scope and definition of a medical device.

Thanks for your reply. Let say if a manufacturer produces a Class I product, but the customer wants to claim it as Class I plus CAT III and the customer having a CE MARK for CAT III (but the manufacturer do not have the CE MARK for CAT III), can the packaging/labeling bear the CE Mark number of the customer?
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: Class I medical device & CAT III PPE

Thanks for your reply. Let say if a manufacturer produces a Class I product, but the customer wants to claim it as Class I plus CAT III and the customer having a CE MARK for CAT III (but the manufacturer do not have the CE MARK for CAT III), can the packaging/labeling bear the CE Mark number of the customer?
Applying the CE mark to a product is a declaration that that product is compliant with all the EU directives that have CE marking provisions, that apply to it. There is no manufacturer discretion about it - a manufacturer can't choose whether or not to claim compliance with a specific CE marking directive. If it applies, based on the product itself and its labeling, compliance is mandatory and the CE mark is a statement that it was achieved.

The repsonsibility for this compliance (all applicable directives) rests with the legal manufacturer - the one whose name and address appear on the labelling. It makes no difference if it was in fact made by another manufacturer (private labeling).
 
Last edited:

pkost

Trusted Information Resource
#4
I don't entirely agree with Ronen about whether the manufacturer has control over the directives they comply with - as a manufacturer they determine the claims they make and therefore have control over which directives they have to comply with:

- If you claim that the product protects the patient from the wearer, then this is a Medical Device and must comply with the MDD
- If you claim that the product protects the wearer from the patient, then this is a PPE product and must comply with the PPED
- If you make claims that the product protects both the patient and the wearer, then you must comply with both MDD and PPED

either the manufacturer or the customer can claim responsibility for compliance, however in doing so they must declare themselves as manufacturer and comply with ALL the appropriate directives.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
I don't entirely agree with Ronen about whether the manufacturer has control over the directives they comply with - as a manufacturer they determine the claims they make and therefore have control over which directives they have to comply with:

- If you claim that the product protects the patient from the wearer, then this is a Medical Device and must comply with the MDD
- If you claim that the product protects the wearer from the patient, then this is a PPE product and must comply with the PPED
- If you make claims that the product protects both the patient and the wearer, then you must comply with both MDD and PPED

either the manufacturer or the customer can claim responsibility for compliance, however in doing so they must declare themselves as manufacturer and comply with ALL the appropriate directives.
I don't see where we don't agree. I specifically wrote:

If it applies, based on the product itself and its labeling, compliance is mandatory
 
#7
Unsure if its acceptable to bump old an old thread on a relevant topic, or create a new thread - apologies in advance if I got this wrong.

I have a relevant question on this topic, if I could kindly ask for advice.

Is there a differentiation between Isolation Gowns and Surgical Gowns relating to PPE Certification? Isolation implies the product isolates both parties - whereby Surgical implies protects the Surgeon - or am I mis-guided?

I understand from the above that if the product "claims" to perform a certain task (ie. protect the patient or protect the Surgeon, or both) then the relevant PPE and/or MDD Certification is required. However, in the case of a Surgical gown - what if no claim about who the product protects is stated. Does the Surgical gown require both PPE and MDD certification by proxy or is a Surgical Gown covered under the MDD certification?

Thank you kindly in advance.
 
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