[ParlTrack]

Proposal for a regulation
Article 17 – paragraph 1

1. The EU declaration of conformity shall state that fulfilment of the requirements specified in this Regulation has been demonstrated. It shall be continuously updated. The minimum content of the EU declaration of conformity is set out in Annex III. It shall be ~~translated into th~~available in one official Union language ~~or languages required by the Member State(s) in which the device is made available~~.

2013/05/14
Committee: ENVI

Richard SEEBER

Proposal for a regulation
Article 21 – paragraph 1

1. Any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re-establish the function of the device without ~~significantly~~ changing its performance or safety characteristics, shall ensure that the article does not adversely affect the safety and performance of the device. Substantiating evidence shall be kept available to the competent authorities of the Member States.

2013/05/14
Committee: ENVI

Richard SEEBER

Proposal for a regulation
Article 25 – paragraph 1

1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information that is necessary and proportionate to describe and identify the device and to identify the manufacturer and, where applicable, the authorised representative and the importer. The details regarding the information to be submitted by the economic operators are laid down in Part A of Annex V. The commission shall decide on one common language as a generally binding language for the registration.

2013/05/14
Committee: ENVI

Richard SEEBER

Proposal for a regulation
Article 35 – paragraph 4

4. T~~hree~~wo years after notification of a notified body, and again every ~~thir~~second year thereafter, the assessment to determine whether the notified body still satisfies the requirements set out in Annex VI shall be conducted by the national authority responsible for notified bodies of the Member State in which the body is established and a joint assessment team designated in accordance with the procedure described in Article 32(3) and (4). At the request of the Commission or of a Member State, the MDCG may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body with the requirements set out in Annex VI.

2013/05/14
Committee: ENVI

Thomas ULMER, Richard SEEBER

Proposal for a regulation
Article 44 a (new)

Article 44a Inspection procedure for notified bodies national authorities responsible for notified bodies 1. The MDCG shall be responsible for standardising the procedures for the initial assessment, notification and monitoring of notified bodies and the notification and monitoring activities of the national authorities responsible for notified bodies. 2. With a view to achieving the objectives referred to in paragraph 1 concerning the standardisation of the work of national authorities responsible for notified bodies, the MDCG shall introduce clear rules on the peer review of national authorities responsible for notified bodies, in accordance with Article 28(8). These rules must be binding for all peer reviews, which shall be carried out every two years by the national authorities responsible for notified bodies in accordance with the annual plan laid down in Article 28(8). 3. Members of the MDCG shall take part in this peer review of national authorities responsible for notified bodies carried out in accordance with Article 28(8). 4. The MDCG shall lay down detailed requirements to be met by the audit experts who carry out the peer review of national authorities responsible for notified bodies in accordance with Article 28(8). 5. With a view to achieving the objectives referred to in paragraph 1 concerning the standardisation of the work of notified bodies, the MDCG shall include experts in the work of conformity assessment bodies and notified bodies. At least two such experts shall be included in the joint assessment team referred to in Article 32(3) set up to monitor the conformity assessment bodies and notified bodies in accordance with Article 35(4). 6. With a view to achieving the objectives referred to in paragraph 1 concerning the standardisation of the work of notified bodies, the MDCG shall lay down detailed requirements as regards the qualifications of the experts responsible for monitoring the work of conformity assessment bodies and notified bodies. 7. The MDCG shall consider the opinion concerning the assessment report and the draft notification drawn up by the joint assessment team pursuant to Article 32(6) and shall decide whether to issue a positive or negative recommendation. This recommendation shall be forwarded to the Commission and the national authorities responsible for notified bodies. 8. Likewise with a view to achieving the objective referred to in paragraph 1, the MDCG shall develop detailed, binding rules for the assessment of conformity assessment bodies and notified bodies. These rules shall incorporate: (a) criteria governing the assessment and notification of notified bodies: - requirements concerning their organisation, quality and management systems and processes; - requirements concerning the requisite resources, including the qualifications and specialist training of their staff; - specific requirements to be met by the auditors and technical assessors who work for notified bodies; - specific requirements to be net by laboratories and subcontractors; - requirements as regards independence, objectivity and discretion. b) Detailed rules governing initial assessments and follow-up assessments: - follow-up assessments shall be carried out regularly, and at least once a year; - follow-up assessments shall be carried out on the spot and cover an assessment of the quality management certificates, type monitoring and design dossier, clinical tests and post-introduction market monitoring, with a special focus on Class III devices and new devices. c) rules and criteria for follow-up assessments carried out on the basis of substantiated concerns; such assessments shall if at all possible be conducted unannounced; d) rules governing the qualification and withdrawal of decisions; e) rules governing an arbitration procedure in the event of disagreement on a negative recommendation in respect of an initial assessment or the qualification or withdrawal of a decision.

2013/05/14
Committee: ENVI

Activities of Richard SEEBER related to 2012/0266(COD)

Plenary speeches (1)

Amendments (5)

ParlTrack - 2011-2024