Medisinsk utstyrsforordning (2017): tillatelse til Maquet Cardiopulmonary GmbH
(Utkast) Kommisjonens gjennomføringsbeslutning (EU) .../... om tillatelse til å bringe på EU-markedet visse medisinske utstyr produsert av Maquet Cardiopulmonary GmbH, i samsvar med europaparlaments- og rådsforordning (EU) 2017/745
(Draft) Commission Implementing Decision (EU) .../... on the authorisation to place on the Union market in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council certain medical devices manufactured by Maquet Cardiopulmonary GmbH
Utkast til kommisjonsbeslutning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 3.4.2023
Nærmere omtale
BAKGRUNN (fra kommisjonsbeslutningen)
(1) Maquet Cardiopulmonary GmbH (MCP), is manufacturing heart-lung support (HLS), permanent life support (PLS) and heparin-induced thrombocytopenia (HIT) sets. These sets are devices intended for extracorporeal membrane oxygenation (ECMO) therapy. With effect from 1 March 2023, the notified body DEKRA Certification GmbH (NB 0124), has suspended the EC certificates for HLS, PLS and HIT sets issued in accordance with Article 16 (6) of the Council Directive 93/42/EEC due to deficiencies linked to the packaging of these devices. EU certificates in accordance with Regulation (EU) 2017/745 have not yet been issued for the same devices. As a consequence, MCP is not allowed to place the HLS, PLS and HIT sets on the Union market as of 1 March 2023.
(2) Given the lack of alternatives for these devices, as a consequence of the certificates’ suspension, there is an acute supply shortage at Union level for patients with an indication for ECMO therapy. If patients with an indication for ECMO therapy cannot be treated immediately, they are at risk of imminent death. It is estimated that the current stocks of HLS, PLS and HIT sets available in the Union will last until the end of March 2023.
(3) On 13 March 2023, in accordance with Article 59 (1) of Regulation (EU) 2017/745, the German competent authority Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices), authorised the placing on the German market of HLS, PLS and HIT sets manufactured by MCP on grounds of interest of public and patient health. Germany notified the Commission and the other Member States on 17 March 2023 of its decision in accordance with Article 59 (2), first subparagraph, of Regulation (EU) 2017/745.
(4) The Commission consulted the Medical Devices Coordination Group (MDCG) to determine whether, in this exceptional case, the validity of the notified German authorisation should be extended to the territory of the Union in accordance with Article 59(3) of the Regulation (EU) 2017/745. Following this consultation the Commission concluded that such an extension is of Union relevance having regard to the fact that the HLS, PLS and HIT sets are essential in all Member States.
(5) Due to the impossibility of treating patients with indication for ECMO therapy were these devices not available, the benefit of saving the life of the patients outweighs the risks resulting from the identified packaging deficiencies, as described in the field safety notice (Ref: 745922 from 31 January 2023), also taking into account available information related to vigilance and market surveillance.
(6) Taking into account the imminent grave consequences in case of unavailability of HLS, PLS and HIT sets manufactured by MCP for patients in all Member States, an extension of the validity of the authorisation granted by Germany to the Union territory is necessary for the protection of public and patient health.
(7) To ensure that the HLS, PLS and HIT sets manufactured by MCP covered by this Decision are placed on the market under controlled conditions and in order to mitigate the risk of infection in patients resulting from the packaging deficiencies, conditions for the placing in the market should be set out. In line with the Commission Communication “Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745” if conditions set for the same devices in national authorisations granted by Member States and in the Union-wide Decision diverge, the stricter conditions should prevail.
(8) The measures provided for in this Decision are in accordance with the opinion of the Committee on Medical Devices.
(1) Maquet Cardiopulmonary GmbH (MCP), is manufacturing heart-lung support (HLS), permanent life support (PLS) and heparin-induced thrombocytopenia (HIT) sets. These sets are devices intended for extracorporeal membrane oxygenation (ECMO) therapy. With effect from 1 March 2023, the notified body DEKRA Certification GmbH (NB 0124), has suspended the EC certificates for HLS, PLS and HIT sets issued in accordance with Article 16 (6) of the Council Directive 93/42/EEC due to deficiencies linked to the packaging of these devices. EU certificates in accordance with Regulation (EU) 2017/745 have not yet been issued for the same devices. As a consequence, MCP is not allowed to place the HLS, PLS and HIT sets on the Union market as of 1 March 2023.
(2) Given the lack of alternatives for these devices, as a consequence of the certificates’ suspension, there is an acute supply shortage at Union level for patients with an indication for ECMO therapy. If patients with an indication for ECMO therapy cannot be treated immediately, they are at risk of imminent death. It is estimated that the current stocks of HLS, PLS and HIT sets available in the Union will last until the end of March 2023.
(3) On 13 March 2023, in accordance with Article 59 (1) of Regulation (EU) 2017/745, the German competent authority Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices), authorised the placing on the German market of HLS, PLS and HIT sets manufactured by MCP on grounds of interest of public and patient health. Germany notified the Commission and the other Member States on 17 March 2023 of its decision in accordance with Article 59 (2), first subparagraph, of Regulation (EU) 2017/745.
(4) The Commission consulted the Medical Devices Coordination Group (MDCG) to determine whether, in this exceptional case, the validity of the notified German authorisation should be extended to the territory of the Union in accordance with Article 59(3) of the Regulation (EU) 2017/745. Following this consultation the Commission concluded that such an extension is of Union relevance having regard to the fact that the HLS, PLS and HIT sets are essential in all Member States.
(5) Due to the impossibility of treating patients with indication for ECMO therapy were these devices not available, the benefit of saving the life of the patients outweighs the risks resulting from the identified packaging deficiencies, as described in the field safety notice (Ref: 745922 from 31 January 2023), also taking into account available information related to vigilance and market surveillance.
(6) Taking into account the imminent grave consequences in case of unavailability of HLS, PLS and HIT sets manufactured by MCP for patients in all Member States, an extension of the validity of the authorisation granted by Germany to the Union territory is necessary for the protection of public and patient health.
(7) To ensure that the HLS, PLS and HIT sets manufactured by MCP covered by this Decision are placed on the market under controlled conditions and in order to mitigate the risk of infection in patients resulting from the packaging deficiencies, conditions for the placing in the market should be set out. In line with the Commission Communication “Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745” if conditions set for the same devices in national authorisations granted by Member States and in the Union-wide Decision diverge, the stricter conditions should prevail.
(8) The measures provided for in this Decision are in accordance with the opinion of the Committee on Medical Devices.