MDR – Article 100 – Electronic system on market surveillance

Article 100

Electronic system on market surveillance

1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information:

(a)summaries of the results of the surveillance activities referred to inArticle 93(4);
(b)the final inspection report referred to in Article 93(7);
(c)information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article 95(2), (4) and (6);
(d)information in relation to non-compliance of products as referred to in Article 97(2);
(e)information in relation to the preventive health protection measures referred to in Article 98(2);
(f)summaries of the results of the reviews and assessments of the
market surveillance activities of the Member States referred to in 93(8).

2. The information referred to in paragraph 1 of this Article shall be immediately transmitted through the electronic system to all competent authorities concerned and, where applicable, to the notified body that issued a certificate in accordance with Article 56 for the device concerned and be accessible to the Member States and to the Commission.

3. Information exchanged between Member States shall not be made public where to do so might impair market surveillance activities and co-operation between Member States.

MDR – Article 92 – Electronic system on vigilance and on post-market surveillance

Article 92

Electronic system on vigilance and on post-market surveillance

1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information:

(a)the reports by manufacturers on serious incidents and field safety
corrective actions referred to in Article 87(1) and Article 89(5);
(b)the periodic summary reports by manufacturers referred to in
Article 87(9);
(c)the reports by manufacturers on trends referred to in Article 88;
(d)the PSURs referred to in Article 86;
(e)the field safety notices by manufacturers referred to in Article 89(8);
(f)the information to be exchanged between the competent authoritiesof the Member States and between them and the Commission in
accordance with Article 89(7) and (9).

That electronic system shall include relevant links to the UDI database.

2. The information referred to in paragraph 1 of this Article shall be made available through the electronic system to the competent authorities of the Member States and to the Commission. The notified bodies shall also have access to that information to the extent that it relates to devices for which they issued a certificate in accordance with Article 53.

3. The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to the electronic system referred to in paragraph 1.

4. On the basis of arrangements between the Commission and competent authorities of third countries or international organisations, the Commission may grant those competent authorities or international organisations access to the electronic system referred to in paragraph 1 at the appropriate level. Those arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent to those applicable in the Union.

5. The reports on serious incidents referred to in point (a) of Article 87(1) shall be automatically transmitted, upon receipt, via the electronic system referred to in paragraph 1 of this Article, to the competent authority of the Member State in which the incident occurred.

6. The trend reports referred to in Article 88(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the Member State in which the incidents occurred.

7. The reports on field safety corrective actions referred to in point (b) of Article 87(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the following Member States:

(a)the Member States in which the field safety corrective action is
being or is to be undertaken;
(b)the Member State in which the manufacturer has its registered place of business.

8. The periodic summary reports referred to in Article 87(9) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authority of:

(a)the Member State or Member States participating in the
coordination procedure in accordance with Article 89(9) and which have agreed on the periodic summary report;
(b)the Member State in which the manufacturer has its registered place of business.

9. The information referred to in paragraphs 5 to 8 of this Article shall be automatically transmitted, upon receipt, through the electronic system referred to in paragraph 1 of this Article, to the notified body that issued the certificate for the device in question in accordance with Article 56.

MDR – Article 73 – Electronic system on clinical investigations

Article 73

Electronic system on clinical investigations

1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system:

(a)to create the single identification numbers for clinical investigations referred to in Article 70(1);
(b)to be used as an entry point for the submission of all applications ornotifications for clinical investigations referred to in Articles 70, 74, 75 and 78 and for all other submission of data, or processing of data in this context;
(c)for the exchange of information relating to clinical investigations inaccordance with this Regulation between the Member States and
between them and the Commission including the exchange of
information referred to in Articles 70 and 76;
(d)for information to be provided by the sponsor in accordance with
Article 77, including the clinical investigation report and its
summary as required in paragraph 5 of that Article;
(e)for reporting on serious adverse events and device deficiencies and related updates referred to in Article 80.

2. When setting up the electronic system referred in paragraph 1 of this Article, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of the Council (1) as concerns combined clinical investigations of devices with a clinical trial under that Regulation.

3. The information referred to in point (c) of paragraph 1 shall only be accessible to the Member States and the Commission. The information referred to in the other points of that paragraph shall be accessible to the public, unless, for all or parts of that information, confidentiality of the information is justified on any of the following grounds:

(a)protection of personal data in accordance with Regulation (EC) No
45/2001;
(b)protection of commercially confidential information, especially in
the investigators brochure, in particular through taking into account the status of the conformity assessment for the device, unless there
is an overriding public interest in disclosure;
(c)effective supervision of the conduct of the clinical investigation by
the Member State(s) concerned.

4. No personal data of subjects shall be publicly available.

5. The user interface of the electronic system referred to in paragraph 1 shall be available in all official languages of the Union.

(1) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).