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Activities of Alda SOUSA related to 2012/0267(COD)

Shadow reports (1)

REPORT on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices PDF (1 MB) DOC (1 MB)
2016/11/22
Committee: ENVI
Dossiers: 2012/0267(COD)
Documents: PDF(1 MB) DOC(1 MB)

Amendments (42)

Amendment 80 #
Proposal for a regulation
Recital 9
(9) To ensure the highest level of health protection, the rules governing in vitro diagnostic medical devices manufactured and used, including measurement and delivery of results, only within a single health institutionsite should be clarified and strengthened.
2013/05/13
Committee: ENVI
Amendment 81 #
Proposal for a regulation
Recital 9 a (new)
(9a) Having regard to the principle of subsidiarity, devices which are produced within health institution laboratories for use in that environment and are not subject to commercial transactions are not covered by this Regulation.
2013/05/13
Committee: ENVI
Amendment 84 #
Proposal for a regulation
Recital 9 b (new)
(9b) However, devices which are manufactured within non-health- institution laboratories and put into service without being placed onto the market are subject to this Regulation.
2013/05/13
Committee: ENVI
Amendment 86 #
Proposal for a regulation
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings.
2013/05/13
Committee: ENVI
Amendment 91 #
Proposal for a regulation
Recital 32
(32) For high-riskClass C and Class D in vitro diagnostic medical devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available.
2013/05/13
Committee: ENVI
Amendment 111 #
Proposal for a regulation
Article 1 – paragraph 6
6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders.
2013/05/13
Committee: ENVI
Amendment 115 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4
(4) ‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including testing services offered to lay persons by means of information society services;
2013/05/13
Committee: ENVI
Amendment 117 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 6
(6) ‘companion diagnostic’ means a device specifically intended to select patients with a previously diagnosed condition or predisposiintended to provide information that is essential for the safe and effective use of a corresponding therapeutic product. The use of a companion diagnostic with a particular therapeutic product is indicated as desirable in the instructions for use in the labelling of both the diagnostic device and the corresponding therapeutic product, as well as in the labelling of any generic equivalents of the therapeutic product or is the stated intended purpose of the diagnostic device. An IVD companion diagnostic device could be essential for the safe and effective use of a corresponding therapeutic product to: – identify patients who are most likely to benefit from a particular therapeutic product; – identify patients likely to be at increased risk for serious adverse reactions as eligible for a targeted therapy; a result of treatment with a particular therapeutic product; – monitor response to treatment for the purpose of adjusting treatment (e.g. schedule, dose, discontinuation) to achieve improved safety or effectiveness.
2013/05/13
Committee: ENVI
Amendment 118 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 10
(10) ‘label’ means the written, printed, or graphic information appearing either on the device itself, or on the packaging of each unit, or on the packaging of multiple devices or on the manufacturer’s website;
2013/05/13
Committee: ENVI
Amendment 119 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
(12a) ‘novel device’ means: – a device which incorporates technology (the analyte, technology or test platform) not previously used in diagnostics, or; – an existing device which is being used for a new intended purpose for the first time;
2013/05/13
Committee: ENVI
Amendment 120 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
(12a) ‘ device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development.
2013/05/13
Committee: ENVI
Amendment 122 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 3 – point 21
(21) ‘health institution’ means an organisation within a Member State’s public healthcare system whose primary purpose is the care or treatment of patients or the promotion of public health; commercial laboratories which provide diagnostic services are not health institutions.
2013/05/13
Committee: ENVI
Amendment 125 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 32
(32) ‘clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological state in accordance with the target popuclinical validity, and if appropriate, the clinical utility of the device in relation andto its intended upurposer;
2013/05/13
Committee: ENVI
Amendment 126 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 32 a (new)
(32a) ‘clinical validity’ means a device’s ability to detect or predict a particular clinical condition or physiological state in relation to its intended purpose (e.g. screening, diagnosis, prognosis);
2013/05/13
Committee: ENVI
Amendment 127 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 32 b (new)
(32b) ‘clinical utility’ means the anticipated effect(s) of the clinical use of the test result, including on health outcomes, where the intended purpose of a device, as stated by the manufacturer, includes a clinical use such as selection of a therapy (e.g. companion diagnostic);
2013/05/13
Committee: ENVI
Amendment 128 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 38
(38) ‘diagnostic specificity’ means the ability of a device to recognize the absence of a target marker associated with a particular disease or conditionproportion of subjects who do not have or a specified clinical disorder whose test results are negative or within the defined decision limit;
2013/05/13
Committee: ENVI
Amendment 129 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 39
(39) ‘diagnostic sensitivity’ means the ability of a device to identify the presence of a target marker associated with a particular disease or condition; proportion of subjects with a well-defined clinical disorder whose test values are positive or exceed a defined decision limit (i.e. a positive result and identification of the subjects who have a disease);
2013/05/13
Committee: ENVI
Amendment 133 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 7 – point 58 a (new)
(58a) ‘laboratory-developed test’ means a device that is manufactured and used only within a single site. This includes devices which a laboratory develops de novo, or develops or modifies from a published source, or develops or modifies from any other source, and devices for which a laboratory: – changes the intended purpose of a device already placed on the market or put into service; – modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
2013/05/13
Committee: ENVI
Amendment 137 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 1
With the exception of Article 59(4), the requirements of this Regulation shall not apply to devices classified as class A, B and C, in accordance with the rules set out in Annex VII, andlaboratory-developed tests manufactured and used only within a single health institution, provided manufacture and use occur solely under the health institution’s single quality management system, and the health institution is compliant withaccredited to standard EN ISO 15189 or any other equivalent recognised standard. Member States may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements.
2013/05/13
Committee: ENVI
Amendment 139 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2
Devices classified as class D in accordance with the rules set out in Annex VII, even if manufactured and used within a single health institution, shall comply with the requirements of this Regulation. However, the provisions regarding CE marking set out in Article 16 and the obligations referred to in Articles 21 to 25 shall not apply to those devices.deleted
2013/05/13
Committee: ENVI
Amendment 144 #
Proposal for a regulation
Article 4 a (new)
Article 4a 1. A device may only be used for the purpose of a genetic test if the indication is given by persons admitted to the medical profession under the applicable national legislation after a personal consultation. 2. A device may be used for purposes of a genetic test only in a way that the rights, safety and well-being of the subjects are protected and that the clinical data generated in the course of the genetic testing are going to be reliable and robust. 3. Information. Before using a device for the purpose of a genetic test the person mentioned in paragraph 1 shall provide the person concerned with appropriate information on the nature, the significance and the implications of the genetic test. 4. Genetic counselling. Appropriate genetic counselling is mandatory before using a device for the purpose of predictive and prenatal testing and after a genetic condition has been diagnosed. It shall include medical, ethical, social, psychological and legal aspects and has to be addressed by physicians qualified in genetic counselling. The form and extent of this genetic counselling shall be defined according to the implications of the results of the test and their significance for the person or the members of his or her family, including possible implications concerning procreation choices. 5. Consent. A device may only be used for the purpose of a genetic test after the person concerned has given free and informed consent to it. The consent has to be given explicitly and in writing. It can be revoked at any time in writing or orally. 6. Testing of minors. In case of minors the informed consent of the parents or legal representative shall be obtained; consent must represent the minor’s presumed will and may be revoked at any time, without detriment to the minor. In case of incapacitated adults not able to give informed legal consent, the informed consent of the legal representative shall be obtained; consent must represent the presumed will and may be revoked at any time, without detriment to the person. Devices predicting a genetic condition that has implications for diseases in adulthood or for family planning shall not be used in minors unless preventive means are available before reaching the age when the person tested is able to give consent. 7. A device may only be used for the determination of sex in connection with prenatal diagnosis, if the determination fulfils a medical purpose and if there is a risk of serious gender specific hereditary diseases. By way of derogation of Article 2(1) and (2) this also applies to products which are not intended to fulfil a specific medical purpose. 8. The provisions of this Article on the use of devices for the purpose of genetic tests do not prevent the Member States from maintaining or introducing for reasons of health protection or public order more stringent national legislation in this field.
2013/05/13
Committee: ENVI
Amendment 145 #
Proposal for a regulation
Article 5 – paragraph 2
2. Without prejudice to national legislation regarding the exercise of the medical profession, aA device that is not placed on the market but is used in the context of a commercial activity for the provision of a diagnostic or therapeutic service offered by any means of information society services as defined in Article 1(2) of Directive 98/34/EC or by other means of communicationcommunication (including by means of information society services) to a natural or legal person established in the Union shall comply with this Regulation.
2013/05/13
Committee: ENVI
Amendment 174 #
Proposal for a regulation
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
2013/05/13
Committee: ENVI
Amendment 186 #
Proposal for a regulation
Article 21 – paragraph 1 – point c
(c) any health instituorganization or healthcare professional to whom they have supplied a device.
2013/05/13
Committee: ENVI
Amendment 189 #
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
(ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices.
2013/05/13
Committee: ENVI
Amendment 239 #
Proposal for a regulation
Article 39 – paragraph 1
1. Devices shall be divided into class A, B, C and D, taking into account their intended purpose, novelty, complexity and inherent risks. Classification shall be carried out in accordance with the classification criteria set out in Annex VII.
2013/05/13
Committee: ENVI
Amendment 273 #
Proposal for a regulation
Article 42 – paragraph 1
1. Notified bodies shall notify the Commission of applications for conformity assessments for devices classified as class D and for devices classified as class C which fulfil the definition of novelty set out in Article 2(12a), with the exception of applications to supplement or renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 17.3 of Annex I and the draft summary of safety and performance referred to in Article 24. In its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG.
2013/05/13
Committee: ENVI
Amendment 291 #
Proposal for a regulation
Article 50 – paragraph 3 – point b
(b) protection of commercially sensitive information,deleted
2013/05/13
Committee: ENVI
Amendment 309 #
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
2013/05/13
Committee: ENVI
Amendment 345 #
Proposal for a regulation
Annex 1 – part II – point 6 – point 6.1 – point b
(b) the clinical performance, including measures of clinical validity such as diagnostic sensitivity, diagnostic specificity, positive and negative predictive value, likelihood ratio, expected values in normal or affected populations; and, where appropriate, measures of clinical utility. In the case of companion diagnostics, evidence of the clinical utility of the device for the intended purpose (selection of patients with a previously diagnosed condition or predisposition eligible for a targeted therapy) is required. For a companion diagnostic, the manufacturer should supply clinical evidence relating to the impact of a positive or negative test on (1) patient care; and (2) health outcomes, when used as directed with the stated therapeutic intervention.
2013/05/13
Committee: ENVI
Amendment 348 #
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.1 – paragraph 1 – introductory part
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and communicate safety and performance related information to the user, professional or lay, or other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and must be made available on the manufacturer's website taking into account the following:
2013/05/13
Committee: ENVI
Amendment 350 #
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point ii – indent 2
– its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, companion diagnostic);
2013/05/13
Committee: ENVI
Amendment 351 #
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point ii – indent 7 a (new)
- for companion diagnostics, the relevant target population and directions for use with associated therapeutic(s).
2013/05/13
Committee: ENVI
Amendment 354 #
Proposal for a regulation
Annex 2 – point 1 – point 1.1 – point c – point ii
(ii) its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, companion diagnosis);
2013/05/13
Committee: ENVI
Amendment 355 #
Proposal for a regulation
Annex 2 – point 1 – point 1.1 – point c – point viii a (new)
(viii a) for companion diagnostics, the relevant target population and directions for use with the associated therapeutic(s).
2013/05/13
Committee: ENVI
Amendment 385 #
Proposal for a regulation
Annex 7 – part 1 – point 1.1
1.1. Application of the classification rules shall be governed by the intended purpose, novelty, complexity and inherent risk of the devices.
2013/05/13
Committee: ENVI
Amendment 386 #
Proposal for a regulation
Annex 7 – part 2 – point 2.3 – paragraph 1 – point f – point i
(i) Devices intended to be used as companion diagnostics; or are classified as a Class C, except when intended to identify patients at risk of life-threatening adverse event, or where the selection decision may lead to the withholding of a potentially life-saving treatment, in which case they are Class D
2013/05/13
Committee: ENVI
Amendment 387 #
Proposal for a regulation
Annex 7 – part 2 – point 2.3 – paragraph 1 – point f – point ii
(ii) Devices intended to be used for disease staging or prognosis; or
2013/05/13
Committee: ENVI
Amendment 388 #
Proposal for a regulation
Annex 7 – part 2 – point 2.3 – paragraph 1 – point j a (new)
(j a) IVDs for the detection and identification of antibodies directed against erythrocytes, platelets, or leucocytes.
2013/05/13
Committee: ENVI
Amendment 389 #
Proposal for a regulation
Annex 7 – part 2 – point 2.6 – paragraph 1
Devices not covered by the above- mentioned classification rules are classified as class B. However, novel class B devices will be classified as class C.
2013/05/13
Committee: ENVI
Amendment 398 #
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 2
– For devices classified as class C and class D according to the rules set out in Annex VII, the clinical performance study report shall include the method of data analysis, the study conclusion and, the relevant details of the study protocol; and the individual data points.
2013/05/13
Committee: ENVI
Amendment 399 #
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 3
– For devices classified as class D according to the rules set out in Annex VII, the clinical performance study report shall include the method of data analysis, the study conclusion, the relevant details of the study protocol and the individual data points.deleted
2013/05/13
Committee: ENVI