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)
Amendments (42)
Amendment 80 #
Proposal for a regulation
Recital 9
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.
Amendment 81 #
Proposal for a regulation
Recital 9 a (new)
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.
Amendment 84 #
Proposal for a regulation
Recital 9 b (new)
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.
Amendment 86 #
Proposal for a regulation
Recital 27
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.
Amendment 91 #
Proposal for a regulation
Recital 32
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.
Amendment 111 #
Proposal for a regulation
Article 1 – paragraph 6
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.
Amendment 115 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4
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;
Amendment 117 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 6
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.
Amendment 118 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 10
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;
Amendment 119 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
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;
Amendment 120 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
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.
Amendment 122 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 3 – point 21
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.
Amendment 125 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 32
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;
Amendment 126 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 32 a (new)
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);
Amendment 127 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 32 b (new)
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);
Amendment 128 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 38
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;
Amendment 129 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 39
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);
Amendment 133 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 7 – point 58 a (new)
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.
Amendment 137 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 1
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.
Amendment 139 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2
Article 4 – paragraph 5 – subparagraph 2
Amendment 144 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 145 #
Proposal for a regulation
Article 5 – paragraph 2
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.
Amendment 174 #
Proposal for a regulation
Article 12 – paragraph 4
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.
Amendment 186 #
Proposal for a regulation
Article 21 – paragraph 1 – point c
Article 21 – paragraph 1 – point c
(c) any health instituorganization or healthcare professional to whom they have supplied a device.
Amendment 189 #
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices.
Amendment 239 #
Proposal for a regulation
Article 39 – paragraph 1
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.
Amendment 273 #
Proposal for a regulation
Article 42 – paragraph 1
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.
Amendment 291 #
Proposal for a regulation
Article 50 – paragraph 3 – point b
Article 50 – paragraph 3 – point b
Amendment 309 #
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
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.
Amendment 345 #
Proposal for a regulation
Annex 1 – part II – point 6 – point 6.1 – point b
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.
Amendment 348 #
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.1 – paragraph 1 – introductory part
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:
Amendment 350 #
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point ii – indent 2
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);
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)
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).
Amendment 354 #
Proposal for a regulation
Annex 2 – point 1 – point 1.1 – point c – point ii
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);
Amendment 355 #
Proposal for a regulation
Annex 2 – point 1 – point 1.1 – point c – point viii a (new)
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).
Amendment 385 #
Proposal for a regulation
Annex 7 – part 1 – point 1.1
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.
Amendment 386 #
Proposal for a regulation
Annex 7 – part 2 – point 2.3 – paragraph 1 – point f – point i
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
Amendment 387 #
Proposal for a regulation
Annex 7 – part 2 – point 2.3 – paragraph 1 – point f – point ii
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
Amendment 388 #
Proposal for a regulation
Annex 7 – part 2 – point 2.3 – paragraph 1 – point j a (new)
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.
Amendment 389 #
Proposal for a regulation
Annex 7 – part 2 – point 2.6 – paragraph 1
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.
Amendment 398 #
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 2
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.
Amendment 399 #
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 3
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 3