Following the meeting of health ministers (EPSCO) on 14 June 2022, the Medical Devices Coordination Group (MDCG), chaired by the Commission, agreed a list of actions to support the capacity of Notified Bodies and preparing manufacturers to facilitate the transition to the Medical Devices Regulation – MDR EUR-Lex – 02017R0745-20200424 – EN – EUR-Lex and the In Vitro Diagnostic Medical Devices Regulation – IVDR EUR-Lex – 02017R0745-20200424 – EN – EUR-Lex Stella Kyriakides, Commissioner for Health and Food Safety, said: “Our rules on medical devices ensure that EU patients have access to safe, life-saving medical devices. The measures we are announcing today aim to address the immediate challenges related to the availability of medical devices for EU patients. By working together, we are committed to finding sustainable solutions to ensure their availability at all times and avoid shortages as a priority. Among the actions listed, the MDCG advises Notified Bodies to use hybrid audits, organize structured dialogues with manufacturers to improve the efficiency of the conformity assessment process, and provide support to small and medium-sized enterprises (SMEs) and new applicants. Manufacturers are urged to make every effort to comply with the new regulatory requirements in a timely manner. The MDCG will continue to monitor the availability of medical devices. The Commission will report to the Council in December 2022.
The European Union joins the Hague Judgments Convention
The European Union has joined today the Hague Judgements Convention, an important tool to facilitate rules-based multilateral trade and investment. The Convention sets out conditions for the recognition and enforcement of judgements in civil and commercial matters, including consumer and employment contracts, and possible grounds for their refusal. The EU’s accession will bring legal certainty and predictability for European businesses, operating in different countries, including outside the EU. Ukraine has also joined the Convention today. Didier Reynders, Commissioner for Justice, said: “Today‘s accession is the culmination of years of intense efforts. By being the first to accede to the Convention together with Ukraine, the European Union paves the way for others to join soon. The wider the accession rate of States to the Hague Judgments Convention, the more powerful an instrument it will become for the benefit of more citizens, more companies, and wider international trade and investment.” To date, six States have signed the Hague Judgments Convention. The Convention was drawn up in 2019, because diverse laws and practices around the globe made recognition and enforcement of foreign judgments challenging, if not impossible. This legal uncertainty as well as the associated costs for businesses often hindered the flow of international trade and investment, ultimately denying them justice.
State aid: Commission seeks feedback on State aid rules for assessing State guarantees on loans
The European Commission has launched today its evaluation of the State aid rules for assessing State guarantees on loans (‘Guarantee Notice’). The initiative consists of: (i) a public consultation to gather views on the Guarantee Notice from all interested parties (including individuals or academia); (ii) an expert consultation to seek feedback from interested parties directly involved in or affected by the provision of State guarantees or with relevant expertise in the field of credit risk (e.g. Member States’ authorities, market participants or non-financial companies); (iii) a request for information to Member States in order to gather consolidated data and information about the practical use of the Guarantee Notice; and (iv) a Call for Evidence seeking feedback on the main aims of the evaluation, its scope and context. The Guarantee Notice provides (i) detailed guidance on how to calculate the aid amount in a State guarantee, (ii) simplified rules for small and medium-sized enterprises (‘SMEs’), including predefined ‘safe-harbour’ premiums, and (iii) guidance on how to design aid-free guarantee schemes for companies of all sizes. By providing guidance on the assessment of State guarantees under EU State aid rules, the Guarantee Notice aims at facilitating access to finance for companies, especially for SMEs, while limiting undue distortions of competition. The Commission finds it necessary to evaluate the Guarantee Notice because, since its last review in 2008, capital requirements have been increased, market conditions and risk management practices have evolved, and Member States have developed several methodologies for granting State guarantees. The Commission will now evaluate whether the Guarantee Notice achieved its objectives and if it is still fit for purpose. To help the Commission, an external contractor will technically analyze the information provided by the Member States in response to the information request. The evaluation will also draw on the experience gathered by the Commission when enforcing the State aid rules in this area. All parties, who have an interest in the matter, can submit their views and respond to the questionnaires in any official EU language on the Commission’s Have your say portal
Statement from the Commission on clarifications discussed with Germany regarding investment protection in the context of the CETA agreement
Today the European Commission published a statement on clarifications discussed with Germany regarding investment protection in the context of the CETA agreement: “The EU and Canada are trusted and like-minded partners that share the same goals when it comes to promoting open, sustainable and fair trade. Our EU-Canada Comprehensive Economic and Trade Agreement (CETA) aims to support our common objective of climate protection. In this context, the European Commission has engaged in constructive discussions with the German Federal Government to prepare a text that clarifies certain provisions in CETA. The result of these technical discussions is a more precise definition of the concepts of ‘indirect expropriation’ and ‘fair and equitable treatment’ of investors. The aim is to ensure that the parties can regulate in the framework of climate, energy and health policies, inter alia, to achieve legitimate public objectives, while at the same time preventing the misuse of the investor to State dispute settlement mechanism by investors.”
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Source: Cyprus News Agency