UDI E CLASSI DI RISCHIO DENTALI

UDI E CLASSI DI RISCHIO

DEI DISPOSITIVI MEDICI DENTALI

Luca Martinelli

Pubblicazione del 05.02.2024

 

1.PREMESSA

Le istituzioni sanitarie e gli operatori sanitari devono registrare e conservare l'UDI dei dispositivi impiantabili di classe III che hanno fornito o che hanno ricevuto.

Per i dispositivi di classe III, diversi dai dispositivi impiantabili, e per i dispositivi impiantabili di classe IIb le istituzioni sanitarie e gli operatori sanitari devono registrare e conservare gli UDI dei dispositivi che hanno ricevuto.

1.1.Dispositivi esclusi dalla registrazione obbligatoria

Le istituzioni sanitarie e gli operatori sanitari su base volontaria, possono registrare e conservare gli UDI dei dispositivi che hanno ricevuto, diversi da quelli indicati precedentemente ovvero i dispositivi di classe IIa e classe I.

I dispositivi indicati nel paragrafo 3 dell'art. 18 del regolamento (UE) 2017/745, ovvero i materiali di sutura, graffette, materiali di otturazione dentale, apparecchi ortodontici, corone dentali, viti, cunei, placche e protesi, fili, chiodi, clip e connettori, sono esclusi.

I dispositivi su misura sono esclusi in quanto non sono dispositivi marcati CE.

Anche i dispositivi sotto direttiva 93/42/CEE, che non rientrano nel campo di applicazione del decreto e che comunque non sono soggetti ad avere un codice UDI, sono da ritenersi esclusi dalla registrazione.

2.LE CLASSI (DI RISCHIO)

Come si fa a sapere a quale classe di rischio appartiene un dispositivo medico?

Prima di tutto è bene ricordare che la classe di rischio viene attribuita dal fabbricante dei dispositivi medici. Una eventuale palese errata classificazione verrebbe però rilevata dall’Organismo di Notificato, che deve certificare il dispositivo, o dall’Autorità Sanitaria.

Dalla certificazione di un Organismo Notificato sono esclusi i dispositivi di classe I ad eccezione delle classi Is (dispositivo fornito sterile), Im (dispositivo con funzione di misura) e Ir (dispositivo chirurgico riutilizzabile).

Le classi non sono, e non devono, essere indicate con i numeri 1, 2 e 3 (come ad esempio per la FDA USA) ma con i numeri romani I, Is, Im, Ir, IIa, IIb e III.

Sull’etichetta del dispositivo medico non è obbligatorio indicare la classe di appartenenza e la stragrande maggioranza dei dispositivi medici non ha tale indicazione.

2.1.Come si può dedurre la classe di rischio?

Una deduzione non è un fatto, l’unico modo sicuro per sapere con certezza la classe di rischio è chiedere al fabbricante la dichiarazione di conformità, meglio ancora il certificato dell’Organismo Notificato (per i dispositivi soggetti a certificazione).

Nel frattempo si può attingere da documenti che indicano la classe di appartenenza, se pur privi di valore legale, che sicuramente ci possono aiutare almeno in un primo screening.

2.2.MDGC 2021-24 Guidance on classification of medical devices

L’allegato VIII dell’MDR 2017/745 fissa le regole di classificazione ma non fornisce esempi di dispositivi medici e relativa classe di appartenenza.

Questa opportunità ci viene invece offerta dall’MDGC Guidance on classification of medical devices. (ottobre 2021).

In esso si possono trovare le regole di classificazione, la relativa classe di rischio e degli esempi di dispositivi medici che sono da considerarsi appartenenti a una determinata classe di rischio.

Il documento, pur essendo redatto ed emesso dal Medical Device Coordination Group Document, non è un documento della Commissione e non è giuridicamente vincolante.

Ad ogni modo non è un documento specifico per un singolo settore medico come ad esempio quello dentale, per questo si trovano pochi esempi inerenti al dentale.

2.3.FIDE classification of dental medical devices

La FIDE, Federazione dell'industria dentale europea con sede a Colonia in Germania, rappresenta gli interessi di oltre 550 produttori di prodotti dentali che sono affiliati alla FIDE attraverso la loro appartenenza ad associazioni nazionali di produttori di prodotti dentali.

Della FIDE fanno parte associazioni nazionale quali:

Associazione austriaca della tecnologia dei metalli; ADDI – L'Associazione dell'industria dentale danese; COMIDENT – Produttori dentali francesi; VDDI - Associazione dei produttori tedeschi di prodotti dentali; UNIDI - Associazione Italiana Industrie Odontoiatriche; INDENT - Associazione dell'industria dentale del Benelux (NL/BE); FENIN - Federazione Spagnola delle Industrie Dentali; ASDI - Associazione dell'industria dentale svizzera; BDIA – Associazione britannica dell'industria dentale.

La FIDE propone una guida molto utile denominata Classification of dental medical devices According Regulation on Medical Devices 2017/745 (MDR) Annex VIII (febbraio 2022) guida anch’essa priva di qualsiasi valore legale, all’interno della quale troviamo una grandissima parte di dispositivi medici dentali con indicata la classe di rischio di appartenenza.

I dispositivi oggetto della guida, con relativa classe di appartenenza, regola di classificazione di riferimento e commento relativo, sono:

 

Product Description	Class	Classification according Annex VIII, MDR	Comments
Adhesives for impression materials	I	Rule 5
Adhesives	IIa	Rule 8	Placed in the teeth“ See also bonder and cements
All-ceramics	IIa	Rule 8
Alloys (for crowns, bridges, inlays, prothetics)	IIa	Rule 8	Placed “in the teeth”
Amalgam	IIa	Rule 8	Placed in the teeth
Amalgam carrier	I	Rule 5
Application-Dispenser	I	Rule 5
Applications-syringes/cannulas	I   IIa	Rule 5   Rule 6	Invasive (e.g. for impression materials)   Surgically-invasive (e.g. for cements)
Arcs, orthodontic	IIa	Rule 5, 3rd indent	Long-term use
Articulation and occlusion materials	I   IIa	Rule 5   Rule 19	If nanomaterial is present
Artificial teeth	IIa	Rule 8
Attachments	IIa	Rule 8	Fixed, long-term use
Bite registration materials	I   IIa	Rule 5   Rule 19	If nanomaterial is present
Blasting abrasives/Powder for dental cleaning including scaling, see prophylaxis powder	I	Rule 5 1st or 2nd indent
Bleaching materials for tooth whitening	IIa IIa	Rule 6 and Rule 7   Rule 19	Content of peroxide >6%   If nanomaterial is present, potential for internal exposure is negligible
Bonder	IIa	Rule 8	Because the tooth is conditioned by insertion, the requirement „in the teeth“ is fulfilled (see also adhesives and cements)

Product Description	Class	Classification according Annex VIII, MDR	Comments
Bone file	Ir	Rule 6
Bone mill	IIa	Rule 2	For channeling and storage of tissues for the purpose of insertion in the body
Bone replacement materials	IIa   III	Rule 8   Rule 8	Not resorbable   resorbable
Bone rongeur, gouge pliers	Ir	Rule 5
Bone scraper (without blade)   Bone scraper (with blade)	I   Ir	Rule 5   Rule 6, 2nd indent	Invasive, transient use   Surgically invasive use
Brackets	IIa	Rule 5	Long-term use
Calcium hydroxide, Calcium salicylate, Calcium sulfate	IIa	Rule 8
Cannulas for intraoral suction	IIa   IIa	Rule 5   Rule 6	Connection to an active device; invasive suction on tooth   Surgical invasive suction on jaw bone
Cannulas for extraoral suction	I	Rule 1
Cavity cleaning agents	IIa	Rule 6
Cavity varnish	IIa	Rule 8
Cements	IIa	Rule 8   Rule 19	(see also adhesives and bonder)   If nanomaterial is present, potential for internal exposure is negligible
Chisel, Bone	Ir	Rule 6	Surgically-invasive
Clamp, artery / Haemostatic forceps	Ir	Rule 6
Clamping wire	IIa	Rule 5, 3rd indent	For long-term use, (see also braces)
Colours for staining	IIa   I	Rule 8   Rule 5	For removable protheses

Product Description	Class	Classification according Annex VIII, MDR	Comments
Compressor, dental compressed air	IIa	Rule 9	Production of energy
Conditioner	IIa	Rule 6	Transient use
Cotton rolls	I	Rule 5
Crowns, dental crowns	IIa	Rule 8
Crown and bridge materials (temporary, provisional)	IIa   IIa	Rule 7 or Rule 8   Rule 19	Depending on usage time   If nanomaterial is present
Crown/Inlay remover	I	Rule 5
Curette	Ir	Rule 6	Surgically-invasive
Data management systems for dental x-ray images	IIb	Rule 11, 2nd indent
Dental casting alloys	IIa	Rule 5	Long-term use in oral cavity
Dental implants and abutments	IIb	Rule 8	Long-term use, not placed “in the teeth”, therefore not class IIa
Dental implants, biological coated	III	Rule 8, 3rd indent	If biological action is claimed
Dental syringe (impression material, rinsing)	I	Rule 5
Dental treatment unit	IIa	Rule 9
Dental operating light	I	Rule 13
Denture adhesive (cream, powder)	IIa	Rule 21, 3rd indent	Application in the oral cavity
Desensitizer	I   I	Rule 5, 1st indent   Rule 5, 2nd indent	For transient use   For short-term use in the oral cavity
Diagnostic devices, dental	IIa	Rule 10	Devices for supporting dental diagnosis
Digital registration unit	I	Rule 13
Disinfection devices	IIa   IIb	Rule 16   Rule 16	Cleaning-/disinfection devices used for disinfection of invasive products as end point of processing

Product Description	Class	Classification according Annex VIII, MDR	Comments
Disinfections	IIa   IIb	Rule 16   Rule 16	Disinfection solutions used for disinfection of invasive products as end point of processing
Direction gauge/ Parallelization pin/ Positioning guide	I	Rule 5
Drill sleeves, stop sleeves	I	Rule 5, first part of sentence	Products are used for transient use of X-ray verification of prosthetic requirements and for guiding surgical instruments. Invasive use in natural body openings.
Electrocautery	IIb	Rule 9
Elevator, dental	Ir	Rule 6	Surgical invasive instrument, reprocessable
Endodontic filling material	IIa   III	Rule 8   Rule 14	Without drug substance   With drug substance
Endodontic instruments	Ir   IIa	Rule 6   Rule 6	Surgically invasive instruments   If used with a handpiece
Endodontic points	IIa	Rule 8	Analogue retention pins, see below
Endodontic rinsing solutions	IIa	Rule 6	Transient use, surgically-invasive product. If the rinsing solution contains chelators (EDTA or citric acid), it is a medical device. In case of NaOCL 5% it is in Germany pharmaceutical, in other EU- countries medical device.
Etching products (intraoral)	IIa   IIa	Rule 6   Rule 19	Transient use   If nanomaterial is present
Excavator, dental	Ir	Rule 6	Surgical invasive instrument, reprocessable
Expansion screws	IIa	Rule 5, 3rd indent	Long-term use

Product Description	Class	Classification according Annex VIII, MDR	Comments
Face bows	I   IIa	Rule 5   Rule 5, 3rd indent	For long-term use
Filling materials (composite, glass- ionomer-cements, ceramic inlays, galvano inlays)	IIa IIa	Rule 8   Rule 19	if nanomaterial is present, potential for internal exposure of nanomaterials is negligible
Filling materials (temporary, provisional	IIa	Rule 7 or Rule 8	Depending on usage time
Forceps, dental	I	Rule 5	Intended use should explain the reasons for which there is no surgical use
Forceps (extraction-, tissue-, root splinter forceps)	Ir	Rule 6	Surgically invasive use; forceps, which come into contact with open wounds
Gauges for verification measurements, Calipper	I	Rule 5
Hand instruments, surgical, e.g. spoons, root elevators, osteotomes, periotome, gingiva punch, bone scraper, luxation instruments, syndesmeotom	Ir	Rule 6
Hand instruments, endodontic (endodontic probes, endodontic ruler/, endodontic spreaders, gutta- percha remover)	Ir	Rule 6
Hand instruments, periodontal e.g. tunneling instruments, periodontal gingivectomy knife	Ir	Rule 6
Handpieces and angled pieces (connected on motor)	IIa	Rule 9
Handpiece with cold light	I	Rule 13	1r product, if reprocessing is required
High frequency devices, surgical	IIb	Rule 9
Holding elements, orthodontic	IIa	Rule 5	Invasive product, used in the oral cavity
Imaging plate scanner	I	Rule 1 and Rule 13

Product Description	Class	Classification according Annex VIII, MDR	Comments
Impression form, dental	I	Rule 5
Impression material	IIa             I	Rule 19, 3rd Indent     If applicable, additional Rule 4     Rule 5	If nanomaterial is present: Potential for internal exposure of nanomaterials is negligible   In contact with damaged mucosa   Without nanomaterial respectively without potential of internal exposure
Impression post	I         Ir	Rule 5         Rule 6	Different use possible: For transient use; No multiple use and no reprocessing; No contact with open wounds   Surgically invasive use in cases, the product is used immediately after insertion of implants and might come into contact with blood and/or damaged mucosa
Impression tray		Rule 5 1st Indent	Transient use; no surgically-invasive instrument, therefore no Class Ir product
Impression (not reprocessable)	I	Rule 5
Insertion tools, manual -screw driver for bone screws/pins -membrane holder	I I	Rule 5   Rule 6, 2nd indent	Use with surgical-invasive indication
Interdental wedges	I	Rule 5
Intraoral camera	I	Rule 13	Active medical device
Intraoral mirrors	I	Rule 5
Instrument stand (bur holder)	I	Rule 1	Accessory for transport of (re-) processable and storage of rotary instruments
Knife holder	Ir	Rule 6	Surgically-invasive
Laser devices (for connection to laser handpieces)	IIb	Rule 9

Product Description	Class	Classification according Annex VIII, MDR		Comments
Liner	IIa   IIa	Rule 8   Rule 19		If nanomaterial is present
Lining materials (cavity)	IIa IIa	Rule 8   Rule 19		Placed “in the teeth”   If nanomaterial is present, potential for internal exposure of nanomaterials is negligible
Mallet, dental	I	Rule 5
Materials against bruxism	I	Rule 5
Materials for guided tissue regeneration	IIb   IIb	Rule 8   Rule 9		Not resorbable   Resorbable
Matrices/-holder	I	Rule 5
Microsurgical instruments (scissors, needle holder, forceps)	Ir	Rule 6		“Ir” in cases the instruments are being used surgically-invasive
Mixing cannula	I   IIa	Rule 5   Rule 6		Invasive use   Surgically invasive-use
Mixing devices	I   I	Rule 1   Rule 13		If manual use   If active medical device
Motor, air driven, turbines	IIa	Rule 9
Mouth Gag, Mouth Gag Retractor	I	Rule 5
Multifunctional handpieces	IIa		Rule 9	Intended for connection to medical devices class IIa
Needle holder	Ir		Rule 6
Osteotome	Ir	Rule 6		Surgically-invasive
Other devices and materials for the preparation of custom-made dental devices	I	Rule 1		Devices according EMDN- Nomenclature under Q010699 (materials for the preparation of custom-made dental devices – other)
Paper points for root-canal cleaning and drying	IIa	Rule 5

Product Description	Class	Classification according Annex VIII, MDR	Comments
Parapulpal pins	IIa	Rule 8	Used in gum openings, but not „surgically-invasive“. Product does not penetrate the body surface, therefore not class 1r.
Patient chair, dental	I	Rule 13	Active product, not suitable for administer
Periodontal probe	I	Rule 5
Photographic chemicals for x-ray film development	I	Rule 1
Pit and fissure sealant	IIa	Rule 5 or Rule 8
Pivot teeth	IIa	Rule 8
Polisher, polishing discs (connected to a handpiece)	IIa	Rule 5 last sentence	Connection to an active device class IIa Rule 19 is not applicable, since particles are contained in a bound manner
Polishing pastes	I	Rule 5, 1st indent	Short-term use in the oral cavity; Product is used for surface smoothing. Application to polishing rollers for spreading on the area to be polished. Subsequent suction or rinsing, therefore no absorption from the body, therefore no application of rule 21.
Polishing strips, separating strips, interproximal strips	I	Rule 5, 2nd indent	No connection to an active device; no active devices; Strips are no surgical instruments, therefore not class 1r, unless placed in the market sterile
Polymer materials for dental trays	I   IIa	Rule 5   Rule 5	Transient or short-term use   Long-term use
Polymerisation lamps	IIa	Rule 9	If intended to a medical device class IIa
Polymerizing devices for hardening	I   IIa	Rule 13   Rule 9	Stand alone   If connection for medical devices of class IIa is present

Product Description	Class	Classification according Annex VIII, MDR	Comments
Powder devices for dental treatment	IIa	Rule 12
Powder jet handpieces	IIa	Rule 9	Air-driven handpiece, used for therapeutic purposes through radiated cleaning powder
Pressure air cleaner, drying of teeth	IIa	Rule 12
Prophylaxis powder, blasting powder, dental Used together with powder jet instruments (see below)	I             IIa	Rule 5, 1st or 2nd indent           Rule 19	Transient use or in case of application in the oral cavity, also in the case of subgingival application class 1 and rule 5, because there is no surgically invasive use   if nanomaterial is present
Prosthodontic materials	IIa	Rule 5
Protected varnish (see varnishes)	I	Rule 5
Pulp capping material	IIa   III	Rule 8   Rule 14	Without drug substance   With drug substance
Pulp vitality measuring device	IIa	Rule 10
Ratchet -torque wrench -ratchet wrench insert	I                 Ir	Rule 5                 Rule 6	If the intended use is „manual insertion of implants or fixing of abutments up to the intended torque. No 1r device, because product does not saw and scratch and does not penetrate through the mucosa, therefor in case of this intended use not surgically invasive.   If the product is used during a surgical treatment and comes into contact with injured mucosa, then the application is surgically invasive(„worst-case-view“)
Relining materials for prostheses	IIa	Rule 21	Application in the oral cavity
Retention pins / root posts	IIa	Rule 8
Retraction cords, -rings	I   III	Rule 5   Rule 14	Without drug substance   With drug substance

Product Description	Class	Classification according Annex VIII, MDR	Comments
Retraction paste	IIa   IIa	Rule 4   Rule 19	Due to haemostatic effect   If nanomaterial is present
Retractor	Ir	Rule 6	Surgically-invasive
Rotary Instruments, connected to a handpiece, invasive   Rotary Instruments, connected to an active handpiece, surgically invasive	IIa   IIa	Rule 5   Rule 6
Rubber Dam, Rubber Dam Frame Support structure for rubber dam	I	Rule 5
Scaler, powered (ZEG handpiece)	IIa	Rule 9	Handpieces, used electrically or air-driven, in conjunction with syringes for dental treatment
Scaler, ultrasound	IIa	Rule 12
Silanisation materials	IIa	Rule 8
Spatula	I	Rule 5
Spoons for gels	I	Rule 5
Sprays   -Anti fog sprays for intraoral mirrors   -Occlusion sprays     -intraoral scan sprays   -Powder sprays	I I IIa     IIa IIa	Rule 5   Rule 5   Rule 19     Rule 21   Rule 19	If nanomaterial is present: Potential for internal exposure of nanomaterials is negligible   Application in the oral cavity   Potential for internal exposure of nanomaterials is negligible
Sterile material container	I	Rule 1
Sterilizer	I	Rule 13
Suction devices, dental	IIa	Rule 12
Suction equipment	IIa	Rule 12	Active MD for removal of body liquids from the body
Suction equipment - cannula	IIa	Rule 5	Rule 5 last sentence: connection to an active device

Product Description	Class	Classification according Annex VIII, MDR	Comments
Suture materials	IIa   III	Rule 7   Rule 7, 14 or 18	Not resorbable   Resorbable, with drugs
Syringes, reusable	I	Rule 5	In the case of invasive application
Syringes, single-use, sterile	IIa	Rule 6
Syringes with anaesthetic (cartridge syringe) without injection needle	I	Rule 5
Tamponades	I   III	Rule 5   Rule 14	Without drug substance   With drug substance
Tooth crowns	IIa	Rule 8
Tooth forming devices (consisting of bonder, brackets, wires)	IIa	Rule 5 3rd indent	Long-term use
Turbines, dental	IIa	Rule 9	High-speed turbine handpiece, air- driven
Ultrasonic device for dental cleaning	IIa	Rule 9
Varnishers (protective varnishers, fluoriding varnishers)	I	Rule 5, 1st or 2nd indent	Short-term or transient use
Veneer, Veneering materials	IIa   IIb	Rule 8   Rule 8	If placed “in the teeth”
Waxes, intraoral	I	Rule 5
Wires, orthodontic (wires, orthodontic arcs for orthodontics)	IIa	Rule 5, 3rd indent	Long-term use
Wound dressing in the oral cavity	I	Rule 5
x-ray devices, dental	IIb	Rule 10
x-ray film	IIa	Rule 17
x-ray film developer	I	Rule 1
x-ray equipment	IIb	Rule 10
x-ray image viewer, dental	I	Rule 13
x-ray imaging plate, dental	IIa	Rule 17

Product Description	Class	Classification according Annex VIII, MDR	Comments
x-ray sensor, dental	IIa	Rule 17

Anche l’ANDI (Associazione Nazionale Dentisti Italiani) nel suo post Obbligo di registrazione UDI – Dispositivi Medici: disponibile il nuovo software ANDI del 21 dicembre 2023, fornisce un utilissima tabella indicante Classificazione,          Descrizione, Ambito odontoiatrico, Obbligo di registrazione UDI ad oggi delle famiglie di dispositivi in uso nel settore dentale.

2.4.Medical devices borderline

Per quanto riguarda alcuni dispositivi medici, sulla cui classificazione non si è in accordo fra fabbricanti, organismi notificati e autorità sanitarie, intervengono alcuni documenti di chiarificazione come ad esempio:

Il Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (Settembre 2023) della Commissione Europea e il MDCG 2022 – 5 - Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (Aprile 2022) del Medical Device Coordination.

In particolare per il settore dentale si tratta circa Product for professional removal of dental biofilm.

Se per gli altri dispositivi è consigliabile chiedere al fabbricante, per quelli borderline è opportuno chiedere sempre senza esitazioni al fabbricante la classe di appartenenza.

3. ASSOCIAZIONI DI CATEGORIA, ALBI PROFESSIONALI, ENTI COMPETENTI

Quanto espresso, compreso le conclusioni, è un punto di vista personale. Per maggiori informazioni
e per approfondimenti rivolgersi alle associazioni di categoria, albi professionali, enti competenti.

4.CONCLUSIONI

1-Le istituzioni sanitarie e gli operatori sanitari devono registrare e conservare l'UDI dei dispositivi impiantabili di classe III, che hanno fornito o che hanno ricevuto e i dispositivi ricevuti di classe III, diversi dai dispositivi impiantabili e dispositivi impiantabili di classe IIb.

2-Sui dispositivi medici la classe di rischio non deve essere indicata obbligatoriamente.

La stragrande maggioranza dei dispositivi medici non ha indicata la classe di rischio.

È  possibile nel frattempo individuare la classe di rischio attraverso documenti privi di valore legale ma molto utili per un inquadramento generale messi a disposizione dalle istituzioni europee, o dai suoi gruppi di lavoro, dalle associazioni dei fabbricanti e non ultimo da ANDI.

3-Per avere sicurezza della classe di appartenenza di un dispositivo di classe III, o IIb è opportuno chiedere il certificato rilasciato dall’Organismo Notificato al fabbricante.

5.BIBLIOGRAFIA

-Ministero della Salute - Decreto 11 maggio 2023 Disposizioni relative alla registrazione e alla conservazione dell'identificativo unico del dispositivo (UDI) da parte delle istituzioni sanitarie e degli operatori sanitari;

-DECRETO LEGISLATIVO 5 agosto 2022, n. 137. Disposizioni per l’adeguamento della normativa nazionale alle disposizioni del regolamento (UE) 2017/745 del Parlamento europeo e del Consiglio, del 5 aprile 2017, relativo ai dispositivi medici;

-REGOLAMENTO (UE) 2017/745 DEL PARLAMENTO EUROPEO E DEL CONSIGLIO

del 5 aprile 2017 relativo ai dispositivi medici;

-Medical Device Coordination Group - MDGC Guidance on classification of medical devices. (ottobre 2021).

-FIDE -Classification of dental medical devices According Regulation on Medical Devices 2017/745 (MDR) Annex VIII. (febbraio 2022);

-ANDI - Dispositivi Medici: disponibile il nuovo software ANDI del 21 dicembre 2023 - URL originale https://www.andi.it/obbligo-di-registrazione-udi-dispositivi-medici-disponibile-il-nuovo-software-andi/ visionato il 05.02.2024;

-Commissione Europea - Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. (settembre 2023);

-Medical Device Coordination Group - MDCG 2022 – 5 - Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. (aprile 2022).