Pöördumine

27 June 2022 Saatja: Tiiu Noobel <[email protected]> Saadetud: 28.06.2022 10:17 Adressaat: SM Info <[email protected]> Teema: FW: Letter of EU Commissioner Kyriakides addressed to EU Health Ministers concerning the implementation of the Medical Device Regulations Tähtsus: Kõrgeim Tere! Edastan Sotsiaalministeeriumi üldaadressil ka. Kiri on registreeritud EV alalises esinduses EL juures 27.06.2022 nr 10.1-13/668 all. Heade soovidega Tiiu Noobel SecretaryPermanent Representation of Estonia to the European Union &#43;32 2227 4337, |Rue Guimard 11/13 1040 Brussels From: Agne Nettan-Sepp &lt;[email protected]&gt; Sent: Monday, June 27, 2022 5:52 PMTo: Triin Uusberg (SoM) &lt;[email protected]&gt;Cc: Elen Ohov (SoM) &lt;[email protected]&gt;; Tiiu Noobel &lt;[email protected]&gt;; Algis Kokka &lt;[email protected]&gt;Subject: FW: Letter of EU Commissioner Kyriakides addressed to EU Health Ministers concerning the implementation of the Medical Device RegulationsImportance: High Tere, Palun edastada ministrile teadmiseks voliniku kiri, mis puudutab meditsiiniseadmete määrust ja asjaolu, et selle üleminekuperioodi lõpuni pole palju aega. Kiri on jätkuks EPSCO AOB punktile, kus samuti komisjon kutsus üles kõiki tegema jõupingutusi määruste õigeaegseks rakendamiseks, et turul ei tekiks probleeme seadmete kättesaadavusega. Informeeritakse mh ka, et järgmine nädal tuleb erakorraliselt kokku vastav koordinatsioonirühm (Medical Devices Coordination Group), mis lahendusvõimalusi täpsemalt arutab (meil katab Terviseamet). Tervitades Agne From: CEKA Klevisa &lt;&gt; Sent: Monday, June 27, 2022 4:49 PMTo: ; ; ; ; ; ; ; Marten Kokk &lt;&gt;; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; Cc: ROSSIDES Giorgos &lt;&gt;; VON BUXHOEVEDEN Daphne &lt;&gt;; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; Esindus EL juures üldaadress &lt;&gt;; Agne Nettan- Sepp &lt;&gt;; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; Subject: Letter of EU Commissioner Kyriakides addressed to EU Health Ministers concerning the implementation of the Medical Device Regulations Your Excellencies, Please find enclosed the correct version of the letter, replacing the inadvertently sent previous version. Please accept our apologies for the inconvenience Kind regards, Klevisa Ceka Assistant to the Cabinets EUROPEAN COMMISSION * BERL 11/088 B-1049 Brussels ( &#43;32 229-65079 : [email protected] Ref. Ares(2022)4688915 - 27/06/2022 STELLA KYRIAKIDES Rue de la Loi, 200 MEMBER OF THE EUROPEAN COMMISSION B-1049 Brussels – Berl 10/380 HEALTH AND FOOD SAFETY [email protected] Brussels, 27 June 2022 Dear Ministers, I write following our discussions on the implementation of the Medical Device Regulations that took place during the EPSCO Council of 14 June 2022 in Luxembourg. During our discussion, I very much appreciated the constructive input of eighteen delegations that took the floor to acknowledge the current implementation challenges and express their willingness to work together to address possible shortages ahead of the end of the transition period in May 2024. This shows how important this topic is for all of us and indeed, our shared responsibility. The COVID-19 pandemic has shown the importance of having production of essential medical supplies in Europe. We must work on viable and pragmatic solutions to prevent that essential medical devices are at shortage from EU markets. Together we must maintain a high level of public health and patient care in our countries. It is absolutely essential that Member States commit the necessary resources to increase the number and the geographical coverage of notified bodies, and to allow existing bodies to make most efficient use of their resources for certifications in accordance with the Medical Device Regulation. We must remain cognizant of market realities. That means that we need to expand the capacity of notified bodies to carry out conformity assessments in a way that adequately takes account of existing devices’ demonstrable track record of safety. Our aim should be to bring all safe and effective devices under the new Medical Device Regulation before the transition period ends. As you know, once the development of a product is stopped or its patent sold to non-EU competitors, it could take years to ensure availability in Europe again, if at all. EU Ministers of Health  It goes without saying that manufacturers must also play their part and make the necessary efforts to demonstrate compliance of their devices with safety and performance requirements in accordance with the new regulations. I would like to encourage all of you to work closely with manufacturers in your Member States to get them ready for the transition. They will need our support in this effort, particularly the small and medium-sized enterprises and those producing niche devices for small patient groups. We need to actively engage with stakeholders to avoid that detrimental decisions on product portfolios are taken now. We must do everything possible to allow companies to invest in research and development and preserve innovation in medical technology taking place in Europe. On 14 June we agreed that we need short-term solutions within the existing regulatory framework to address the immediate challenges. We also agreed that simple extension of the transition period would not solve the underlying structural problems. Many delegations suggested during EPSCO that the Medical Devices Coordination Group (MDCG) should propose mitigating measures aiming at enhancing notified body capacity and ensuring the availability of medical devices in the EU. The Commission has drawn up a list of possible short-term mitigation actions and an extraordinary meeting of the MDCG will take place on 4 July to endorse these actions in principle. Please ensure that your MDCG representatives are fully empowered to speak on your behalf and are ready to endorse necessary short-term solutions. Active outreach towards stakeholders to present these actions will then start as of September 2022. At the same time, we also need to reflect together on how to ensure the most optimal and sustainable framework for the medium and long term, both in terms of patient safety and device availability. The Commission is ready to prepare the necessary elements for this approach, ahead of our next discussion on this topic at the EPSCO Council in December. Yours sincerely, Electronically signed on 27/06/2022 14:46 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121