Person Responsible for Regulatory Compliance
To contact the person responsible for regulatory compliance regarding any concerns arising from Article 15, paragraph 3 of MDR 2017/745, please use the contact form below.
Summary of article 15, paragraph 3 of the MDR 2017/745:
(3) The Person Responsible for Regulatory Compliance shall at least be responsible for ensuring that:
- a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released,
- b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date,
- c) the post-market surveillance obligations are complied with in accordance with Article 10(10),
- d) the reporting obligations referred to in Articles 87 to 91 are fulfilled,
- e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
——Contact form Person Responsible for Regulatory Compliance
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