biocide or medical device

7/24/2019 Biocide or Medical Device

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REACH – CLP-

Biocide

Solutions

Biocide and Medical device

The Scope of the biocide regulation

( Regulation (EU) No 528/2012 of the European Parliament and of the Council of

22 a! 2012 concerning the ma"ing a#aila$le on the mar"et and u%e of $iocidal

product%)

In the preamble of this regulation is set:

&'iocidal product% intended to $e u%ed not onl! for the purpo%e% of thi%

Regulation $ut al%o in connection ith medical de#ice% %uch a%

di%infectant% u%ed to di%infect *+++, medical de#ice% ma! po%e ri%"% other

than tho%e ith hich thi% Regulation i% concerned+ -herefore %uch

$iocidal product% %hould compl! in addition to the re.uirement% laid donin thi% Regulation ith the rele#ant e%%ential re.uirement% %et out in

nne to Council irecti#e 30/485/EEC of 20 une 1330 on the

approimation of the la% of the em$er 6tate% relating to acti#e

implanta$le medical de#ice% Council irecti#e 34/72/EEC of 17 une 1334

concerning medical de#ice% and irecti#e 38/3/EC of the European

Parliament and of the Council of 2 9cto$er 1338 on in #itro diagno%tic

medical de#ice%:

In Article 2 of this regulation is set: when a biocidal product falls within the

scope of one of the following instruments and is intended to be used for

purposes not covered by these, the biocidal regulation shall also apply to thatbiocidal product insofar as those purposes are not addressed by these

instruments:

1. medicated feedingstu (!ouncil "irective #$%1&'%!)2. implantable medical devices (!ouncil "irective #$%*+%!). medical devices (!ouncil "irective #%2%!). in vitro diagnostic medical devices (- and !ouncil "irective #*%'#%!)+. veterinary medicinal products (- and !ouncil "irective 2$$1%*2%!,

egulation (!) /o '2&%2$$)&. medicinal products for human use (- and !ouncil "irective 2$$1%*%!,

egulation (!) /o '2&%2$$)'. additives for use in animal nutrition (egulation (!) 1*1%2$$)*. hygiene of foodstus and hygiene rules for food of animal origin

(egulation (!) /o *+2%2$$, egulation (!) /o *+%2$$)#. food additives (egulation (!) /o 1%2$$*)1$.0avorings and certain food ingredients (egulation (!) /o 1%2$$*)11.feed (egulation (!) /o '&'%2$$#)12.plant protection products (egulation (!) /o 11$'%2$$#)1.cosmetics (egulation (!) /o 122%2$$#)1.toys (- and !ouncil "irective 2$$#%*%!)

Does address the Council Directive 93/42/EEC the

disinfection of medical Devices?

A medical device means any instrument, apparatus, appliance, software,

material or other article, whether used alone or in combination, including the

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software intended by its manufacturer to be used speci3cally for diagnostic

and%or therapeutic purposes and necessary for its proper application.

4he disinfection is mentioned in the "irective 5ust in ule 1+ on classi3cation of

medical devices:

&ll de#ice% intended %peci;call! to $e u%ed for di%infecting cleaningrin%ing or hen appropriate h!drating contact len%e% are in Cla%% $+

ll de#ice% intended %peci;call! to $e u%ed for di%infecting medical de#ice%

are in Cla%% a+ Unle%% the! are %peci;call! to $e u%ed for di%infecting

in#a%i#e de#ice% in hich ca%e the! are in Cla%% $+:

Dierent o!cial interpretations"

#$ %&'gence nationale de s(curit( du m(dicament et des produits de

sant( )'*S+,- .rance

<EU $iocidal product% Regulation 528/2012 hich came into force on6eptem$er 1%t 2014 allo% a manufacturer to put on the mar"et a product

ith intended u%e% that fall under the %cope of $iocidal product %tatu% and

under the %cope of medical de#ice %tatu%+ n thi% ca%e the product i% in

compliance ith $oth regulation%:1

2$ +edicines and ealthcare 0roducts 1egulator 'genc )+1',-

nited ingdom

<-he EU Regulation 528/2012 co#ering $iocide% came into force in

6eptem$er 2014 and contain% pro#i%ion for product% intended for $oth

general di%infectant u%e and u%e ith medical de#ice%+ n %uch a ca%e $oththe regulation% co#ering medical de#ice% and tho%e co#ering $iocide%

ould appl! to a %ingle product and the product %hould $e la$elled in

accordance ith $oth %et% of regulation%+: 2

5n conclusion

6e may announce that the "irective on medical devices does not address the

disinfection purpose, and thus the biocidal regulation shall apply also for

those medical devices which are used for disinfection.

1 A/78, 7tatus of disinfectants used in the medical sector (9orderline with biocidal products -42

and medical devices), uly%2$1,

http:%%ansm.sante.fr%var%ansm;site%storage%original%application%2*ecbe2dcb2*c1'*2*2c+$&bc#f

add.pdf

2 8<A, =uidance on legislation 9orderlines with medical devices, >ebruary%2$1, pg 1$,https:%%www.gov.u?%government%uploads%system%uploads%attachment;data%3le%2*+$+%9orderlines;

with;medical;devices.pdf

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Conse6uences

1. The medical device should be labeled according to biocidal

regulation also.2. Supplier of medical device should comply with Article 95 of

biocidal regulation:<% of 1 6eptem$er 2015 a $iocidal product con%i%ting of containing or

generating a rele#ant %u$%tance included in the li%t referred to in

paragraph 1 %hall not $e made a#aila$le on the mar"et unle%% either the

%u$%tance %upplier or the product %upplier i% included in the li%t referred to

in paragraph 1 for the product=t!pe(%) to hich the product $elong%+:

The supplier of such medical device shall declare in written form for

the Hungarian authority that the active substance used in the

product is in conformity with Article 95, and the supplier of active

substance is declared on the !HA"s #$ist of active substances and

suppliers%.

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Classi7cation and labelling of medical devices according

to C%0

(Regulation (EC) No 122/2008 of the European Parliament and of the Councilof 1> ecem$er 2008 on cla%%i;cation la$elling and pac"aging of %u$%tance%

and miture% amending and repealing irecti#e% >/578/EEC and 1333/75/EC

and amending Regulation (EC) No 130/200>)

4his egulation shall not apply to substances and mi@tures in the following

forms, which are in the 3nished state, intended for the 3nal user:

1. medicinal products as de3ned in "irective 2$$1%*%!2. veterinary medicinal products as de3ned in "irective 2$$1%*2%!. cosmetic products as de3ned in "irective '&%'&*%!. medical devices as de3ned in "irectives #$%*+%! and #%2%!,

which are invasive or used in direct physical contact with the humanbody, and in "irective #*%'#%!

+. food or feeding stus as de3ned in egulation (!) /o 1'*%2$$2

including when they are used:a. as a food additive in foodstus within the scope of "irective

*#%1$'%!b. as a 0avouring in foodstus within the scope of "irective

**%**%! and "ecision 1###%21'%!

Conclusion

>or medical devices used as disinfectants the provisions of !B- regulation shallapply.

Conse6uences

4he products shall be classi3ed and labeled according to !B- from 1 une 2$1+.

Cnly the product which are placed on the mar?et befor 1 une 2$1+ may be

classi3ed according to "irective 1###%+%!.

?placing on the mar"et@ mean% %uppl!ing or ma"ing a#aila$le hether in

return for pa!ment or free of charge to a third part!+ mport %hall $e

deemed to $e placing on the mar"et+

?import@ mean% the ph!%ical introduction into the cu%tom% territor! of the

Communit!A

?importer@ mean% an! natural or legal per%on e%ta$li%hed ithin the

Communit! ho i% re%pon%i$le for importA

4he responsibility for import depends on many factors such as who orders, who

pays, who is dealing with the customs formalities, but this might not be

conclusive on its own. A <ungarian !ompany may be considered importer if this

pays the invoiced ammount to a legal entity whisch is not stabiliDed in the!ommunity (ie. 7witDerland).

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4his means, any product which is imported in the uropean &nion after '

(une )*'5 has to be classi+ed, labeled and paced in conformity with the

provisions of !$- regulation. 4his obligation is for the manufacturer or the

importer. In case the manufacturer outside of uropean Enion (ie. 7witDerland)

does not ma?e this classi3cation and labelling, then the importer should do this.

-eter 7Da?acs

!hemical safety specialist8ember of !hemical <aDard !ommunication 7ociety, Enited Fingdom

4o@ichem Btd.<G&'21 7Deged, CsDtrovsD?y 2'phone: H& $ ###G''*2 eGmail: [email protected]

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