Aggiornamenti sulle attività del Gruppo europeo Borderline and Classification

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1 52 SIMPOSIO AFI Rimini maggio, 1 giugno 2012 Aspetti regolatori e di progettazione nei dispositivi medici borderline Aggiornamenti sulle attività del Gruppo europeo Borderline and Classification Maria Grazia Leone Direzione Generale dei Dispositivi Medici, del Servizio Farmaceutico e della Sicurezza delle Cure Ministero della Salute (mg.leone@sanita.it)

2 Istruzioni per l uso della presentazione ATTENZIONE Le proposte riportate nelle prossime diapositive non hanno ancora il marchio CE! Costituiscono solo una base per le successive discussioni a livello europeo e come tali potrebbe subire sostanziali modifiche.

3 Agenda Definizione di borderline Gruppo ad hoc sui prodotti borderline farmaci dispositivi medici Modifiche alla linea guida MEDDEV 2.1/3 rev 3 Proposta di nuove regole di classificazione per i dispositivi medici per os

4 Cosa è un prodotto borderline? Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices Version 1.12 ( ) I prodotti borderline sono quei prodotti che per loro natura non appartengono con chiarezza ad un determinato settore, per i quali quindi è difficile definire quale sia la normativa di riferimento da applicare.

5 Cosa è un prodotto borderline? Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices Version In alternativa prodotti borderline sono quei prodotti che rientrano nella definizione di dispositivo medico ma sono esclusi dal campo di applicazione della direttiva. Quando un prodotto non rientra nella definizione di dispositivo medico riportata nella direttiva o ne è escluso dal campo di applicazione della direttiva stessa, si applicano altre direttive o normative di riferimento.

6 APP PRESS SIC GEN PROD AIMD COMP EMC RIFIUTI e IMBALL

7 Direttive 2001/83/EC e 2007/47/EC: definizioni Medicinale: n ogni sostanza o associazione di sostanze presentata come avente proprietà curative o profilattiche delle malattie umane; o n ogni sostanza o associazione di sostanze che possa essere utilizzata sull uomo o somministrata all uomo allo scopo di ripristinare, correggere o modificare funzioni fisiologiche, esercitando un azione farmacologica, immunologica o metabolica, ovvero di stabilire una diagnosi medica Dispositivo medico: qualunque strumento, apparecchio, impianto, software,sostanza o altro prodotto, utilizzato da solo o in combinazione, compresi gli accessori tra cui il software destinato dal fabbricante ad essere impiegato specificamente con finalità diagnostiche e/o terapeutiche e necessario al corretto funzionamento del dispositivo stesso, destinato dal fabbricante ad essere impiegato sull uomo a fini di: n diagnosi, prevenzione, controllo, trattamento o attenuazione di malattie, n diagnosi, controllo, trattamento, attenuazione o compensazione di una ferita o di un handicap, n studio, sostituzione o modifica dell anatomia oppure di un processo fisiologico, n controllo del concepimento, che non eserciti nel o sul corpo umano l azione principale cui è destinato con mezzi farmacologici, immunologici o mediante processi metabolici, ma la cui funzione possa essere coadiuvata da tali mezzi

8 Novità introdotta dalla direttiva 2007/47/EC Art. 1 comma 5c This Directive does not apply to: omissis (c) medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or the present Directive, particular account shall be taken of the principal mode of action of the product;

9 D. Lgs 37/2010 Art.2 comma 3 Il presente decreto non si applica: omissis c) ai medicinali soggetti al decreto legislativo 24 aprile 2006, n. 219, che recepisce il codice comunitario sui medicinali per uso umano. Nello stabilire se un determinato prodotto rientri nell'ambito di applicazione di tale decreto oppure del presente decreto si deve tener conto in particolare del principale meccanismo d'azione del prodotto stesso;

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11 Ad hoc working group on borderline cases between medical devices and pharmaceuticals AC per dm (IT, NL, DE, SE, IR, PT, ES, UK, LV), EU COM AC per farmaci (GR, UK, EMA, CHMP), EU COM 1 riunione 10 marzo 2011 Meeting on demand in order to support the more complicated decisions on borderline products by involving experts from the two sectors.

12 Action point IT, DE, NL will create a working group in order to draft new definitions for metabolic, pharmacological, immunological and chemical means.

13 MEDDEV 2.1/3 rev 3 In deciding whether a product falls under the MDD particular account shall be taken of the principal mode of action of the product Pharmacological mean Immunological mean Metabolic mean

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15 MEDDEV 2.1/3 rev 3 (December 2009) Pharmacological means is understood as an interaction between the molecules of the substance in question and a cellular constituent, usually referred to as a receptor, which either results in a direct response, or which blocks the response to another agent. Although not a completely reliable criterion, the presence of a dose-response correlation is indicative of a pharmacological effect. Immunological means is understood as an action in or on the body by stimulation and/or mobilisation of cells and/or products involved in a specific immune reaction. Metabolic means is understood as an action which involves an alteration, including stopping, starting or changing the speed of the normal chemical processes participating in, and available for, normal body function. Note: The fact that a product is, or is not, itself metabolised does not imply that it achieves, or does not achieve, its principal intended action by metabolic means.

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17 Amendment to the definitions of pharmacological, immunological and metabolic means as reported in the MEDDEV 3.1/3 Rev.3

18 MEDDEV 2.1/3 rev 3 Pharmacological means is understood as an interaction between the molecules of the substance in question and a cellular constituent, usually referred to as a receptor, which either results in a direct response, or which blocks the response to another agent. Although not a completely reliable criterion, the presence of a dose-response correlation is indicative of a pharmacological effect.

19 Pharmacological means (proposal) is understood as an interaction between the molecules of the substance in question and a constituent of a biological system (the whole human body or any of its parts), which either results in a direct response, or which blocks the response to another agent. This biological constituent could be a receptor like e.g. a membrane protein, an ion channel or an enzyme; the interaction is generally made of different types of bindings leading to the mediation of a response at a cellular or molecular level. They may also modify an entity or combine with it in order to alter the interaction of the entity itself with the body. The principle described above also applies to the interaction between a substance and a pathogenic organism. Although not a completely reliable criterion, the presence of a doseresponse correlation is indicative of a pharmacological effect.

20 MEDDEV 2.1/3 rev 3 Immunological means is understood as an action in or on the body by stimulation and/or mobilisation of cells and/or products involved in a specific immune reaction.

21 Immunological means (proposal) is understood as an action in or on the body by stimulation and/or mobilisation of cells and/or products involved in a specific immune reaction. Each substance, not recognized as endogenous (xenobiotic), administered to the human body can produce an immune response, being recognized as non-self. It must be clear that a means of action can be considered immunological only when the immune response is the primary intended consequence of the administration of a substance. On the other hand an immune response that is not the intended consequence of administration, cannot be considered an immunological mode of action.

22 MEDDEV 2.1/3 rev 3 Metabolic means is understood as an action which involves an alteration, including stopping, starting or changing the speed of the normal chemical processes participating in, and available for, normal body function. Note: The fact that a product is, or is not, itself metabolised does not imply that it achieves, or does not achieve, its principal intended action by metabolic means.

23 Metabolic means (1) (proposal) is understood as an action which involves an alteration, including stopping, starting or changing the speed of the normal chemical processes participating in, and available for, normal body function. Metabolism is the set of chemical reactions, that happen in the cells of living organisms to sustain life. It includes processes for cell growth, reproduction, response to environment, survival mechanisms, sustenance, and maintenance of cell structure and integrity.

24 Metabolic means (2) (proposal) With regard to the concept of chemical process the binding between molecules which does not mediate, directly or indirectly, a response within or on the human body is considered a chemical, not a metabolic mode of action. A typical chemical mode of action is the local ph modification or the sequestering action of a molecule. The chemical mode of action should be reproducible in vitro in a closed not biological inert system.

25 FDA (21 U.S.C. 321(h)) In the FDA definition of a medical device instead of the concept of pharmacological, immunological and metabolic means the term "chemical action" as a subordinate concept is used. However, although using a different wording, the borderline between medical devices and medicinal products is practically the same. The FDA definition reads as follows: "A device is: intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

26 FDA guidance Classification of Products as Drugs and Devices and Additional Product Classification Issues (Draft guidance (06/2011) Interpretation of the Term "Chemical Action" in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (Draft guidance (06/2011)

27 Interpretation of the Term "Chemical Action" III. WHAT DOES CHEMICAL ACTION MEAN? Under the Agency s interpretation, a product exhibits chemical action for purposes of the device definition at section 201(h) of the FD&C Act if: Through either chemical reaction or intermolecular forces or both,the product: Mediates a bodily response at the cellular or molecular level, or Combines with or modifies an entity so as to alter that entity s interaction with the body of man or other animals.

28 Proposta di nuove regole di classificazione per i dispositivi medici per os

29 Medical device medicinal product ad hoc working group on borderlines cases... Outcome: the members suggested qualifying the product as a medical device. However, they strongly recommended in parallel, a revision of the classification rules for ingested products in the medical device Directive. Action point: The United Kingdom, Portugal and Dutch's delegations will draft a proposal.

30 Proposta di nuove regole di classificazione per i dispositivi medici per os Regola 5 (attuale) Tutti i dispositivi invasivi in relazione con gli orifizi del corpo, diversi dai dispositivi invasivi di tipo chirurgico, che non sono destinati ad essere allacciati ad un dispositivo medico attivo o che sono destinati ad essere allacciati ad un dispositivo medico attivo appartenente alla classe I: - rientrano nella classe I se sono destinati ad un uso temporaneo omissis - rientrano nella classe IIa se sono destinati ad un uso a breve termine omissis - rientrano nella classe IIb se sono destinati ad un uso a lungo termine omissis

31 Proposta di nuove regole di classificazione per i dispositivi medici per os Regola speciale? (proposta italiana) Rule 19: Ingested medical devices, and their products of biotransformation, that are not systemically absorbed are in class IIb Ingested medical devices, and their products of biotransformation, that are systemically absorbed, regardless of their absorption level, are in class III.

32 Grazie per l attenzione!