European Ombudsman

1. Report on the meeting of the European Ombudsman inquiry team with representatives of the European Commission on how it ensures the transparency of the expert group on Medical Device Coordination

   Date: Friday, 22 September 2023

   Remote inspection arrangements

   Webex video call organised by the European Ombudsman, 14:00 - 16:00

   Present

   European Commission

   Head of Unit, SANTE.D3 (Medical Devices)

   Deputy Head of Unit, SANTE.D3

   Legal Officer, SANTE.D3

   Policy Officer, SANTE.D3

   Legal and Policy Officer, SANTE.D3

   Co-ordinator for Inter-Institutional Relations, Relations with the European Ombudsman, SG.C2

   European Ombudsman

   Ms Amandine le Bellec, Inquiries Officer

   Mr Koen Roovers, Inquiries Officer

   Ms Jennifer King, Legal Expert

   Mr Krzesimir Wawrzyczek-Seifert, Inquiries Trainee

   Purpose of the meeting

   The purpose of the meeting was for the Ombudsman inquiry team to meet with the

   relevant representatives of the Commission to clarify certain matters that arose when

   analysing the Commission’s reply and the complainant’s comments

2. Decision on how the European Anti-Fraud Office (OLAF) carried out an on-the-spot check of the premises of a Polish company (case 2304/2023/MIK)

   The complainant is a Polish company that is the subject of an investigation by the European Anti-Fraud Office (OLAF) into possible fraud against the EU budget. The complainant raised concerns with how OLAF conducted an ‘on-the-spot check’ on the complainant’s premises. In particular, the complainant contended that: its management board had not been informed about the inspection; one of the OLAF ‘investigators’ that conducted the check had not provided adequate proof of his identity in the context of Polish law; the authenticity of the OLAF’s authorisation to carry out the check could not be verified; and the investigators had demonstrated bias against the complainant.

   The Ombudsman found no maladministration in how OLAF had carried out the on-the-spot check.

3. Decision on how the European Commission ensures the transparency of the Medical Device Coordination Group (case 2132/2022/KR)

   This case concerns the transparency of the Medical Device Coordination Group, a group of experts that provides advice to the European Commission on the implementation of EU legislation and rules concerning medical devices. The complainant was concerned that the Commission failed to make public all relevant documents concerning the MDCG, as its rules require. In particular, the complainant was concerned that the Commission does not make public draft guidance documents before they are ‘endorsed’ by the MDCG.

   In the course of the inquiry, the Commission committed to disclose proactively further background documents, which the Ombudsman welcomed. The Commission also said that its practice is to assess documents individually with a view to their potential proactive disclosure, including draft guidance documents to be ‘endorsed’ by the MDCG, which is in line with the MDCG’s terms of reference and rules of procedure. Therefore, the Ombudsman considered that no further inquiries were

4. Comments of the complainant on the reply from the European Commission regarding how it ensures the transparency of the expert group on Medical Device Coordination

   Please download pdf document attached.

5. Reply from the European Commission to the European Ombudsman on how it ensures the transparency of the expert group on Medical Device Coordination

   Please download pdf document attached.