EUROPEAN COMMISSION D G E N TE TE R P R I S E Directorate G U n i t 4 - P r e s s u r e E q u i p m e n t , M e d i c a l D e v ic i c e s , M e t r o l og og y
MEDICAL DEVICES: Guidance document ME DDE V 2.4/ 2.4/1 1 R ev.8 J u l y 20 20 01 01
G U I D E L I N E S F O R T H E C L A S S I F I C AT AT I O N O F M E D I C AL AL D E V I C E S
The present Guidelines are part of a set of Guidelines relating to questions of application of ECDirectives on on medical devices. They are legally not binding. The Guidelines Guidelines have been carefully carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts were circulated and and comments were were taken up in the document. Therefore, this document document reflects positions taken by representatives of interested parties in the medical devices sector. Note :
This document document is a revisi revision on of an earlie earlierr documen documentt publishe published d in Decem December ber 1999 1999 as as MEDDEV. 2.4/1 rev. 6
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P U R P O SE S E AN A N D P H IL I L O S O P H Y O F M E DI D I C A L DE D E VI VI CE CE CL ASSIF IC ATION .. .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .. P R AC A C T I C AL AL R E L E VA V A N C E O F CL C L AS AS S I F I C AT A T I O N . .. ... ... .. ... ... . 2.1. Gen er a l r equ ir em en t s. .... ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ...... .. 2.2. Confo Conforr m it y a sses sm en t .... ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ...... 2.3. Clinical data............................................................................... 2.4. L a belli n g ........... ...................... ...................... ...................... ...................... ....................... ....................... ................. ...... 2.5. Mis cella n eous .......... ..................... ...................... ...................... ...................... ...................... ....................... ............
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HO W TO CARR Y OUT CLASSIF ICATIO N ... ...... .... ...... ...... .... ...... .... ...... .... ...... ...... .... 3.1. Ba sic defin it ions ........... ...................... ...................... ...................... ...................... ...................... ................. ...... 3.2. Application rules........................................................................ 3.3. How to use t he r ules a nd th e decision decision tr ee ... ...... ...... ..... ..... ..... ..... ..... ..... ..... ..... ..... 3.4. P r a ctica l exa m ple ........... ...................... ..................... ..................... ...................... ..................... ................ ...... 3.5. Handling of interpretational problems.....................................
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E XP X P L AN A N AT A T I O N S O F I N D I VI V I D U AL A L R U L E S .. ... .. ... .. ... ... .. ... .. ... 4.1. Gr ap hical su mm ar y - Guida nce cha rt ... ...... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... .. 4.2. General explanation of rules/Practical issues/Examples.........
A P P E N D I C E S: 1. Annex IX of the Medical Device Directive
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P U R P O S E AN D P H I L O S O P H Y O F M E D I C A L D E V I C E CLASSIFICATION It is not feasible economically nor justifiable in practice to subject all medical devices to the most rigorous conformity assessment procedures available. A gradu at ed system of of cont rol is more appr opria te. In such a system, the level of control corresponds to the level of potential hazard inh eren t in t he t ype of of device device conc concern ern ed. A medical device device classific classificat at ion ion system is therefore needed, in order to channel medical devices into the proper co conform nform ity assessmen t r out e. In order to ensure that conformity assessment under the Medical Device Directive functions effectively from January 1995, manufacturers should be able to know as ear ly as possible possible in which which class class t heir pr oduct is. Identification of the class of each individual type of device by a committee procedur procedur e would would ha ve taken too long long to achieve achieve this goal. goal. It wa s th erefore erefore decided to set up a system of classification rules within the directive, so th at each ma nu factur er could could classify classify its its own devices. devices. A simple set of classification rules based on technical features of medical devices existing now and in the future is impossible, because of the vast nu mber an d th e cha nging na tu re of of varia bles involve involved. d. The hu ma n body, body, however, however, is a relatively un cha nging element of of th e equat ion. ion. The Eu ropean legislator legislator est ablished t her efo efore a classific lassificat at ion ion concept wh ich ich is essentially based on potential hazards related to the use and possible failure of devices taking account of technology used and of health policy considera tions. This appr oach in tur n allows allows the use of of a sma ll set of of crit eria t ha t can be combined combined in var ious ious wa ys: dur at ion ion of cont act with th e body, body, degree of invasiveness an d local local vs. system ic effec effect. t. It is recognized that although the existing rules will adequately classify th e vast ma jorit jorit y of of existing existing devices, devices, a sm all n um ber of dif difficult icult cases m ay ar ise. Such cases may in par ticular include include th e deter mina tion of th e border border line between between two classes. In addit ion ion th ere ma y be devic devices tha t cannot be classified by the existing rules because of their unusual nature or situations where the classification would result in the wrong level of conform nform ity assessmen t in light of th e hazar d repr esented by th e devic device. e.
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P R AC A C TI T I CA C A L R E LE L E VA VA N CE C E O F C LA L A S SI S I F IC I C AT AT IO IO N
2 .1 .
Genera l req uir emen ts All All devices devices m us t: m ee ee t t h e es es s e n t ia ia l r eq e q u ir ir em em en e n t s irrespective of the class of the device (see also Ann Ann ex VIII VIII of th e Directive) be subjec subjectt to the reporting reporting requi requirements rements under the medic medical dev devic icee vigilance system; be CE CE m arked (ex (exccept custo customm-made made devic devices es and devic devices es intended intended fo for clinical invest igat ion). ion). Note: If Ann ex VIII VIII a pplies pplies (c (cust om m ade devices devices and devices devices intended for clinical investigation) then all its requirements apply irrespective of the class of the device. Class I custom made devices need not be acco accompa nied by the st at ement referred t o in Annex VIII VIII (Art (Art . 4). 4).
2 .2 .
C on o n fo f o r m it i t y A s s es e s s m en en t
CONFORMITY ASSESSMENT PROCEDURES AN N E XE S II (+ Sect.4) Sect.4) II (- Sect. 4) III IV V VI VII VI I
CLASSES
I
I sterile
I meas.
II A
II B
III
Ö Ö
Ö
Ö Ö Ö Ö
Ö Ö Ö Ö
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Ö Ö Ö Ö
Ö Ö Ö Ö Ö
Ö Ö Ö
2 .3 .
C l i n ic i c a l d a ta ta 2 .3 .3 .1 .1 . C l in in i c a l e v a l u a t i o n The Medical Devices Directive states that as a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in sections 1 and 3 of Annex I of Directive 93/42/EEC under the normal conditions of use of the device device an d t he evalua tion of th e un desirable side-ef side-efffects ects mu st be based on on clinical clinical dat a. This r ule applies in part icular icular in th e case case of implan ta ble devices devices a nd devices devices in class I II (Annex X, section section 1.1) 2 .3 .3 .2 .2 . C l i n i c a l in in v e s t i g a t i o n Clinical investigation with Class III devices and implantable and long-term invasive devices falling within Class II A or II B may start 60 days after their notification to the Competent Authority unless a negative decision from the Competent Authority has been received received with with in t his t imefra imefra me. (Art (Art . 15)
2.4.
I n s t r u c t io i o n s fo fo r u s e Instructions for use are not required for Class I and II A devices if these devices devices can can be used sa fely fely without su ch in st ru ct ions ions (Ann (Ann ex I Sect Sect . 13.1.) 13.1.)..
2.5.
Miscellaneous The manufacturer, or persons responsible for marketing of a Class I product and designated by the manufacturer, must notify their address and the devices concerned to the Competent Authority of the Member Sta te wh ere t hey ha ve their r egister egister ed place place of of business business (Art (Art . 14) 14).
3.
H OW O W T O CA C A R R Y O U T CL C L AS S I F I C AT I O N The manufacturer should first decide if th e product co concerned is a medical medical device device as defined in the Directive 93/42 93/42 or an accesso accessory ry t o such such a medical medical device device an d if it if it t her efo efore comes comes wit hin th e sco scope of th is Directive. Active implantable devices and devices for in vitro diagnosis are covered by separ at e directives, directives, which which do not a pply th e classifi classificcat ion ion ru les reviewed reviewed in th ese Guidelines. Guidelines.
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3 .1 .
B a si s i c d ef e f i n it i t io ion s The classification rules are based on terms related to duration of contact with the patient, degree of invasiveness and the part of the body affected by th e use of of th e device device.. These t erm s ar e defined defined in Section Section I of Ann ex IX of the Directive and reproduced below, together with some additional guidance. 3 . 1 .1 . T im im e 3.1. 3.1.1. 1.1. 1. Du r a t ion Transient Norm ally intend ed for continu continu ous use for for less less than 60 m inu tes.
S h or or t t e r m Norm ally intend ed for for co cont inu ous u se for for not m ore tha n 30 d ays.
Long ter m Norm ally intend ed for for continu continu ous u se for for m ore ore th an 30 d ays.
3 .1 .1 .1 .1 .2 .2 C o n c e p t o f c o n t i n u o u s u s e Concepts of duration such as transient, short term and long term ar e defined defined in in ter ms of of cont inuous use. Cont Cont inuous use must be understood as an uninterrupted actual use for the intended pur pose. pose. For insta nce, a scalpel scalpel ma y be used on on th e sam e pat ient th roughout roughout an operat operat ion ion tha t may last last fo for several several hour hour s. The uninterrupted use for an intended purpose, i.e. cutting tissue, will norma lly not last for for more th an a few sec seconds at a t ime. Therefore Therefore a scalpel is a tr an sient u se devic device. e. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device (e.g. replacement of a ureteric catheter) this shall be considered an exten sion sion of th e contin contin uous u se of t he device.
3 .1 .2 .2 . I n v a s i v e n e s s
I n v a s i ve ve d e v i c e s -6 -
A device wh ich, ich, in wh ole or or in part, penetrates inside th e body, body, either through a body orifice or through the surface of the body.
B o d y o r i ffii c e Any natural opening in the body, as well as the external surface of th e eyeball eyeball,, or or an y perma nent a rtificial rtificial opening, opening, such as a stoma .
S u r g i c a ll l l y in in v a s i v e d e v i c e An invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation. For the pu rposes rposes of thi s Directive Directive d evices evices oth oth er tha n th ose referred referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices.
There a re t wo exceptio exceptions ns t o th is: A surgically created stoma used in colostomy and ileostomy or p e r m a n e n t tracheostomy is considered to be a natural body or ific ifice. e. Ther efor efor e devices devices int int r odu ced ced int int o such a stoma a r e not su rgically inva sive. A su r gically gically cr cr eat ed openin openin g t o allow access access to the circulatory system in contrast should not be considered to be such a "na "na tu ra l body body orific orifice" e".. Devices Devices intr odu ced int o su ch an opening are surgically invasive. A device that administers energy to the body should not be considered a s invasive if only energy penet ra tes t he body and n ot th e devic devicee itself. itself. En ergy as such is not a device device and t her efo efore it can not be classified. lassified. Only th e devic device genera genera tin g th e energy mu st be class ified. ified. However, if a devic devicee ad min ister s a subst an ce, ce, whether this substance is a medicine or a medical device, such a substance must be assessed in its own right (e.g. substances adm inister ed by a jet injector). injector). Any device which, in whole or in part, penetrates inside the body, either through a natural body orifice or through the surface of the body body is is an in vasive devic device. A sur gically gically invasive device device alwa ys implies th at it ent ers th rough an ar tific tificially crea ted opening. opening. This can be a large opening, such as a surgical incision, or it can be a pinprick opening created by a needle. Therefore surgical gloves and needles used with syringes ar e sur gically gically invasive. invasive. -7 -
I m p l a n t a b l e d e v i ce ce Any d evice evice wh ich ich is in tended: -
t o b e t ot ot al al l y i n tr t r od u ce ced in i n to t o t he h e h u m a n bo bod y or , t o r ep ep la la ce ce a n ep ep it it h el el ia ia l su su r fa fa ce ce or t h e s u rf rf ac ace of t h e ey e, e,
by surgical intervention which is intended to remain in place after th e proce proced d u re. Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device.
One of the key elements in defining what is an implantable device is the concept of of "procedur procedur e". e". Thu s an implan ta ble devic device mu st rem ain in th e pat ient after th e procedur procedur e. A "procedur procedur e" mu st be un derst ood in this cont ext to include include th e sur gical gical pr ocedur e dur ing which which t he implan t is placed into the body and the immediate post-operative care that is associated with t he procedu procedu re. The" pr ocedu cedu re" does not exten d to th e conclusion conclusion of of t he th erapeut ic tr eatm ent, e.g. e.g. th e removal removal of an implant must be co considered to be an oth er "proc "procedur edur e". e". Thu s a plat e used to redu ce a fractur e of of th e bo bone is an implant even even if it is ta ken out out a fter t he fra fra ctu re has healed. In th is case the placing of the plate and its explantation are two different surgical procedures. Some partially implanted devices are deemed to be implants. For instance, if an operat ion ion is car car ried out to specif specific ically ally to place place an infusion infusion port port into th e body, body, th en such a n infusion infusion port would would r ema in for for a t least 30 days after after th e procedur procedur e and consequen consequen tly be an im plant . However, However, a sut ur e used fo for skin woun woun d clo closur sur e tha t is tak en out out pr ior ior t o 30 days is is not an implant . 3.1. 3. 1.3. 3. Active d evic es D e f i n i t i o n o f a c t i v e m e d i c a l d e v i c e ( An An n e x I X S e c t . I c la l a u s e 1 .4 .4 ): ): An y m edical device th e operati operati on of w h ich d epen epen ds on a source of electric electrical al energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices devices intend ed to transm it energy, energy, substa nces nces or other ele elem m ents between between an active medical device and the patient, without any significant change, are n ot consid consid ered ered to be active m edical d evices. evices.
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The concept oncept “act by convert convert ing en ergy” includes conver conver sion sion of ener gy in t he devic device an d/o d/or conversion at th e int erface erface between t he device device an d t he t issues or in th e tissues. The concept of “significant changes” includes changes in the nature, level and density of energy (see rule 9). This means th at for instan ce an elec electr tr ode is not a n active devic devicee un der th is classif classific icat at ion ion system as long long as th e energy input is intended to be th e same as the energy energy out put. For insta insta nce, nce, resistance in a wire that causes minor changes between input and output cannot be considered to constitute "significant change". For example electrodes used in electrosurgery for cutting tissues or cauterisation are active devices because their operation depends on energy provided by a generator and their action is achieved by conversion of energy at the interface between the device and the tissue or in the tissue. Electrodes intended for E.C.G. or E.E.G are normally not active devices because they do not normally act by conversion of energy. However, it should be un derst ood th at an elec electr ode, which which is an a ccessory essory of of an active implan t, is covered un der th e relevant directive directive for active implan ts. Fu rt her information on this issue can be found in "Guidelines relating to the application of the Council Directive 90/385/EEC on active implantable m edical d evices (Med.Dev. (Med.Dev. 2.1/2). 2.1/2). The application of energy from the human body does not make a device "active" unless that energy is stored within the device for subsequent release. For inst inst an ce, energy generat ed by hu ma n muscle an d applied to the plunger of a syringe (thus causing a substance to be delivered to a pat ient) does does not ma ke th is syringe an "active "active devic device" e".. However, However, if if a dru g delivery delivery system system depends upon m an ua l winding to preload a spr ing which which is subsequently released to deliver a substance, then the device incorporating the spring is an "active device". Medical Medical devices devices using pr estored gases a nd/or nd/or vacuu vacuu m as a power power sour ce ar e regarded as active devices, e.g. gas mixers with anesthesia machines and gas powered powered su ction pum p s. Hea tin g/c g/cooling pads int ended only to release stored t her ma l energy ar e not active devices because they do not act by conversion of energy. However, heating/cooling pads which act by chemical action (e.g. endothermic or exothermic reaction) are active devices as they are converting chemical energy into heat energy an d or vic vice versa. Radioactive sources that are intended to deliver ionizing radiation are regar ded as active medical medical devic devices, un less they are r adiophar ma ceut icals icals as defined in article 2 of Directive 89/343/EEC or radioactive implants as defined in ar t icle icle 1 of Directive 90/385/EEC. 90/385/EEC. -9 -
3 . 1 .4
D ev e v ic i c e s w it i t h a m e a su s u r i n g fu fu n c t io io n See ME DDEV 2.1/5 2.1/5
3 .2 .2 .
Ap p l i c a t i o n r u l e s
In ter ms of fur th er in ter pret at ion ion of th e decisio decision n r ules, the follo following wing should be considered considered : - It is the intended purpo p urpose se that determines determines the class class of of the devi devicce and not the particular technical characteristics of the device, unless these have a direct direct bear ing on on th e int int ended pur pose. pose. - It is the intended intended and not the acc ac cidental idental use of of the devic devicee that deter mines th e class class of of th e devic device. For insta nce a sut ur e organ organ izer, izer, tha t is intended to keep order in the maze of the many threads of sutures used in open heart surgery, should not be considered as an invasive devic device if if in th e norm norm al use it can can be kept out out side th e patient . Similarly, if a medical practitioner uses the device in a manner not intended by the ma nu factu factu rer , this does not cha cha nge th e class class of th e devic device fo for t he pu rpose of conformity assessment. - It is the intended intended purpose purpose assig assigned ned by by the manufactur manufactur er to the devi devicce th at deter mines t he class class of th e devic devicee an d not th e class class assigned t o oth er similar similar produc products. ts. For instan ce two sutu res th at have th e same composition mposition ma y well have diff differen t int ended pu rposes. - As an alter na tive to classifyi lassifying ng the system as a whole whole,, th e deter mina tion of the class of a particular device may be made with respect to the simplest configuration that can still be considered, in view of its proper fun ctional feat feat ur es, as a devic device in its own own r ight. A devic device tha t is par t of a system, e.g. a tube in an extra corporeal circulation set, may be classed as a d evic evice in its own own r ight r at her th an classifying lassifying th e system as a whole. whole. Similarly combination devices with parts that have different functional pur poses, poses, ma y be be ana lysed lysed separa tely with with respect to each each of of th ese part s. For instance, a drainage device will have an invasive tube and a noninvas ive collec collectt ion ion devic device. e. These co comp onent s ma y be clas clas sified sified separately. - Accessories essories mu st be classif classified ied separ at ely from th eir par ent device. device. - If a give given n devic device can can be classi classiffied ied acco according to several several r ules, th en t he highest possibl possiblee class applies. For inst an ce, a wo woun d dressing incorp incorp orat ing co collagen is co covered by ru les 4 (Clas (Clas s I, Class II a or Class IIb depending on on int ended use) and 17 (Class III ). - 10 -
- If th e devic devicee is not int ended to be used solely solely or pr incipally incipally in in a sp ecif ecific ic part of the body, it must be considered and classified on the basis of the most crit ical ical specified specified use. Classificat Classificat ion ion of t he device device will will ha ve to be determined on the basis of claims contained in the information provided with t he devic device. The ma nu factur er mu st be suffic sufficiently iently specif specific ic in th at regard . If the manufacturer wants to avoid the particular higher classification, then it must clearly define on the labelling the intended pur pose pose in such such a way way tha t th e devic device falls int o th e lower lower class. class. The manufacturer must provide as a minimum requirement ei ther appr opriat e positive positive or or negat ive ive indicat indicat ions ions for for use . For a device to be "specifically intended" for the purpose referenced in a part icular icular classific lassificat at ion ion ru le, th e ma nufactu nufactu rer mu st clear lear ly indic indicat at e th at the device is intended for such a specific purpose in the information acco accompa nying the device. device. Oth erwise it is deemed to be int int ended to be be used principally for the purpose that is accepted in general medical practice.
3 .3 .
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Multi-application equipment cameras, which may be used not medical devices unless ma rk et with specif specific ic int ended
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Sta nda lone lone softwa softwa re, e.g. e.g. sof softwa re which is used for for im age enha ncement is regarded as driving or influencing the use of a device and so falls automatically into the same class. Other standalone software, which is not regarded as driving or influencing the use of a device, is classified in its own own right .
such as laser printers and identification in combination with medical devices, are their manufacturer places them on the pu rpose as m edical edical devices. devices.
H ow ow t o u s e t h e r u l e s The manufacturer must take into consideration all the rules in order to est ablish t he pr oper classific classificat at ion ion for for h is device. device. It is qu ite conceivable conceivable fo for instance that one of the general rules that are not specific to active devices, devices, never th eless app lies to su ch a device. device. All All t he device device cha ra cter istics istics mu st be ta ken into considera tion. The cha ra cter istic or combina tion of cha ra cter istics istics in acco accorda nce with with th e int ended pu rpose of of the device that rates the highest class determines the class for the device as a whole. whole.
3 .4 .4 .
P r actical exam ple Exam ple: a wound dra inage device device
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A simple woun woun d dra inage devic devicee has t hr ee co component s th at mu st be ta ken int o considera tion: th e can can nu la, th e tubing and th e co collec llector un it. If th e device is sold without a cannula, then the classification of the cannula does does not need t o be tak en int o acco accoun t. It is assumed here that the device is used for a short term duration, i.e. that uninterrupt ed intended intended use is is more than 60 minut minut es and less less than 30 days. It is fur th erm ore assu med tha t the co collec llected liquids liquids ar e not intended to be re infused into the body nor reprocessed for eventual re infusion and that the device is not intended to be connected to a powered suction suction system . In t en d ed u ses
R u le
Sur gic gically invasive invasive can can nu la t o rea ch a woun woun d site in th e pleur pleur al cavity cavity to drain t he cavity cavity Non-invasive tubing to evacuate body liquids towards the collector. Non-invasive collec collector tor to r eceive eceive th e body liquids.
C la s s
7
II A
1
I
1
I
The clear clear conclusion nclusion h ere is th at th e ma nu factur er would ha ve a choic choicee of of applying Class II A to the whole device or carrying out separate conformity assessment procedures for the cannula on one hand and the tu bing and colle collecctor on th e oth oth er h an d. 3 .5 .
H a n d li l i n g o f i n t e r p r e t a ti t i o n a l p r o bl b l e m s. s.
In case t he m an ufactur er is u nsu re h ow its devices devices should be classif classified, ied, it should first first consu consu lt a Notified Notified Bo Body. In case doubt doubt s rem ain or th ere is a disagreement with the Notified Body, the relevant Competent Competent Aut hority sh ould be app roached in acc accorda nce with Art . 9 of t he Directive. In addit ion, ion, t he Directive provides provides Comm Comm un ity wide mecha mecha nism s, including including a comm itt ee pr ocedur e, to addr ess pr oblems r elated to classifi classificcat ion. ion. 4.
E XP XP L AN AN A T I O N S OF O F I ND N D I VI VI D U A L R UL UL E S The explana explana tions ar e giv given en in th e fo following llowing man ner . This section section begins begins with a gra phical phical sum mar y of of the ru les les , as a preface to subsections on the individua individua l ru les. Ea ch subsection subsection sta rt s with with a general explana explana tion of th e rule followed by a t abu lar pr esenta tion of of th e rule an d examples of of devic devices to which which it applies. Any special special term s used are explained explained and pr actical actical issues relat ed to th e rule ar e clar clar ified. ified. It must be emphasized that even if a particular device type is given as an example, this does not mean that such devices are in all cases in the class - 12 -
indicat indicat ed by th e example. It is always possible possible th at some ma nu factur er will assign to such a device an entirely different intended use than what was u sed in th e co cont ext of of th e example.
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4 .1
G r a p h i ca c a l su s u m m a r y – m e d i ca c a l d ev e v ic i c es e s cl c l a s si s i fi fi c a t io io n g u i d a n c e c h a r t f o r i n i t i a l i d e n t i fi f i ca c a t i o n o f p r o b a b l e d e v i ce ce class
Note: A l w a y s c o n f i r m d e f i n i t i v e c l a s s i f i c a t i o n b y r e a d i n g a ll r u l e s i n detail, and utilise additional assistance in this guidelines d o c u m e n t a s p r o v i d e d i n t h e fo f o r m o f g e n e r a l e x p l a n a t i on o n s o f r u l es es a n d e x a m p l e s o f d e v i c e s (s ( s e e s e c t i o n 4 .2 .2 ) S U BJ BJ E C T S Non in vasive devices devices – Ru les 1, 2, 3, 4 In vasive devices devices – Ru les 5, 6, 7, 8 Act Act ive devices – Rules 9, 10, 11, 12 Special ru les – Ru les 13, 14, 15, 16, 16, 17, 18 Remember! The char acterist ics ics or combina combina tion of cha ra cter istics istics in acco accorda nce with the intended purpose of the device that rates the highest class determinates the clas clas s for for t he device as a wh ole. ole. NON INVASIVE DEVICES
Rule 1 Either do not touch patient or contact only intact skin
Rule 2 Channelling or storing for eventual administration
Class I
Class I
or
Rule 3 Modify biological or chemical composition of blood, body liquids, other liguids intended for infusion
Rule 4 In contact with injured skin (mechanical barrier absorb exudates)
Class IIb
Class I
or
or
For use with blood, other body fluids, organs, tissues
May be connected to an active medical device
Class IIa
Class IIa
or
Only filtration, centrifugation or exchange of gas or heat
Intended for wounds which breach dermis and heal only by secondary intent
Class IIa
Class IIb
or Intended to manage microenvironment of wound + others
Class IIa
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INVASIVE D EVICES
Rule 6 Surg ically invas invas ive - transient use
Rule 5 Invasive in body orifice or stoma (not surgically surgically ) or
T ra nsi en t u se
Shor t term u se
Class I
Connected to an active medical device of Class IIa or higher
L on g t erm u se
Class IIa
Class IIb Class II a
or
Diagnose/control Diagnose/control - defect of heart/ central circulation system
Supply energy/ ionizing radiation
or
Class IIb IIb Class III III
or
If only in oral cavity, ear canal or nasal cavity cavity
or
Cla ss IIa IIa
Reusable surgical instrument
If only in oral cavity, ear canal or nasal cavity cavity
or Biological effect -mainly absorbed
Class I
Class IIb Class I
Class IIa or System to administer administer m edicines edicines - potentially hazardous
Cla ss IIb IIb
INVASIVE DEVICES
Rule 8 Surgically invasive Long-term use and implantable devices
Rule 7 Surgically invasive Short-term use
II b or Specifically to monitor/correct defect of heart or central circulatory system - by direct contact
Class II a
or
or Supply energy/ ionizing radiation
or
To be placed in teeth
Biological effect or mainly absorbed or
II a
II b
III or
or III or
For use in direct contact with central nervous system III
Biological effect mainly absorbed III or Undergo chemical change in body - or administer medicines (NOT in teeth) II b
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Used in direct contact with heart or central circulatory/ nervous system
Undergo chemical change in body - or administer medicines (NOT in teeth)
III
III
ACTIVE DEVICES
Rule 10
Rule 9 Active therapeutic devices intended to administer or exchange energy
Active device for diagnosis. May supply energy, for "imaging purpose" monitor vital physiological processes
Active devices to administer remove medicines & other substances to or from the body
IIa
IIa
IIa
or
Rule 11 Rule 12 All other active devices
I
or or
or Administer or exchange energy in potentially hazardous way IIb
Intended to control & monitor or influence directly a class IIb active therapeutic device
Special rule All devices emitting ionizing radiation and related monitors in medical procedure
IIb
IIb
If this is in a potentially hazardous way
When used to monitor vital processes where variations could result in immediate danger
IIb IIb or SPECIAL RULE All devices emitting ionizing radiation and related monitors in medical procedure IIb
SPECIAL RULES
Rule 13 Devices incorporating integral medicinal product liable to act in ancillary way on human body
Rule 15 Specific for disinfecting, cleaning, rinsing devices for contact lenses
Rule 17 Devices utilizing animal tissues or derivatives (not devices in contact only with intact skin)
III
IIb
III
or Rule 14 Devices used for contraception or prevention of sexually transmitted diseases
IIb or
For disinfecting other medical devices other than by physical action
Rule 16 Non active devices to record X-ray diagnostic images
Rule 18 Blood Bags
IIa
IIb
IIa
If implantable or long-term invasive III
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End Part 1 ...... P a r t 2 : ... ... S e e n e x t d o c u m e n t ( st st a r t i n g w i t h p a g e 1 6 a g a i n ) .
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