Manufacturers except for manufacturers making custom-made devices , authorised representatives and importers must all register with the database. However, manufacturers of custom-made devices, distributors and specialist shops must still be registered with the Danish Medicines Agency. The various EUDAMED modules will become operational continuously, and therefore it is not required that all information is reported as from 26 May For a period, it will still be possible to market medical devices conforming with the requirements stipulated in previous legislation.
Accordingly, any medical devices still in the supply chain which have not reached the end-user may continue to be made available on the market until 27 May After this date, the medical devices must be recalled. However, certificates issued by notified bodies in accordance with the directives in force at the time will only remain valid until the end of the period indicated on the certificate, or until 27 May , whichever comes first.
After 27 May , certificates issued in accordance with the directives become void, and it will only be possible to sell the associated products if said products have already been brought into circulation on the European market. Plesner will continue to keep an eye on the interpretation of the obligations under the new regulation. Please contact us if you need advice on what the new regulation means for your company, and how you ensure that you comply with the new requirements.
Read the new regulation on medical devices. Manufacturers Among other things, manufacturers should note that the regulation entails that clinical investigations of medical devices for human subjects will be subject to more stringent rules. The Due Diligence Strategy Document, which will need to be evaluated and revised if necessary on an annual basis, will need to:. Indicate the appropriate policies and measures adopted by the company, with a view to ceasing, preventing, or mitigating the identified potential or actual adverse impacts; and.
Enforcement of the mandatory regime under the Directive will fall on the competent national authorities of EU member states, who will have the power to carry out investigations into compliance, including by conducting interviews with stakeholders and their representatives, and carrying out on-the-spot checks.
Based on the usual timeline for legislation adoption at EU level approximately 19 months , we expect that the Directive will be adopted in late , at the earliest. Following this adoption, EU member states will be given time to transpose the Directive into national law, which is usually a maximum period of 2 years - meaning binding national laws would not be expected before However, given the extent of these obligations, companies expecting to be subject to the new regime under the Directive will need to begin to consider necessary steps to reach compliance and potentially upgrade the measures already implemented under national regimes such as those in Germany, France and the Netherlands , to ensure all required measures are in place before the Directive comes into force.
Gabriela advises clients on a wide range of competition matters, including restrictive practices and agreements, abuses of dominance, merger control, procurement and state aid. Gabriela has extensive experience in advising manufacturers in a variety of sectors, including leading consumer electronics, sports and fashion brands, on designing and implementing effective distribution Jennifer Marsh is partner in the firm's London office.
She concentrates her practice on all aspects of EU and UK competition law and commercial agreements. She advises clients on public procurement law as well as European and competition law. She is particularly experienced in advising clients on the design of and participation in complex procurement procedures, privatization projects and public private partnerships for both the bidding and the contracting party. Annette Mutschler-Siebert also advises clients on issues relating to antitrust law, in particular the structuring of distribution networks, the structuring of One focus of her practice is the comprehensive advice of bidders and public clients on public procurement law, both in connection with the design and monitoring of complex public procurement procedures and the representation in review proceedings.
Helene also advises clients on all antitrust law issues, in particular in the area of merger control law, antitrust compliance, Catherine Adam is a partner in the firm's London office. She has experience in a range of industries with a particular focus on clients in the retail, fashion and leisure sectors.
She advises on B2B and consumer matters for e-commerce retailers, fashion brands and traditional retailers as well as high end restaurant groups. Catherine's retail experience encompasses supply chain issues with a particular focus on third party logistics warehousing and fulfillment. For her fashion clients who range from global brands to early stage market entrants, Catherine advises on licensing, Skip to main content.
New Articles. Villalobos and Ayumary M. Tea and Kelsi E. Heiden and Audrey R. Congress Passes Wochner and Laurie B. Walsh Jr and Jeffery R. Swor and Rachel L. Kennedy, Jr. Rinearson and Andrew M. Adler What is an organization required to do in Europe if it engages in Zetoony Computing on the Edge by: Robert M. National authorities must communicate these measures to the European Commission.
Transposition must take place by the deadline set when the directive is adopted generally within 2 years. When a country does not transpose a directive, the Commission may initiate infringement proceedings and bring proceedings against the country before the Court of Justice of the EU the non-enforcement of the judgment on this occasion can lead to a new conviction which may result in fines. It is important to distinguish between minimum and maximum or full harmonisation requirements in directives.
In the case of minimum harmonisation , a directive sets minimum standards, often in recognition of the fact that the legal systems in some EU countries have already set higher standards. In this case, EU countries have the right to set higher standards than those set in the directive. In the case of maximum harmonisation , EU countries may not introduce rules that are stricter than those set in the directive.
Protection of individuals in the event of incorrect transposition of directives. In principle, the directive only takes effect once transposed.
However, the Court considers that a directive that is not transposed can produce certain effects directly when:. When these conditions are met, individuals may rely on the directive against an EU country in court. The table of the transposition of EU directives on the single market , published by the Commission in December , shows that 20 countries were not able to achieve this goal and that only 1 country managed to achieve a compliance deficit for national legislation of below the 0.
Skip to main content. This document is an excerpt from the EUR-Lex website.
0コメント