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The procurement of MDs and IVDs

The procurement of MDs and IVDs

The procurement ecosystem should be aware that products certified under the Directives and products certified under the Regulations will coexist on the market until May 2025. During this period both types of certification will have equal status under the law and no discrimination in public tenders may take place.

To avoid market disruption and allow a smooth transition from the Directives to the Regulations, several transitional provisions are foreseen in the Regulations, because the new Regulations require the designation of notified bodies and introduce more stringent requirements for manufacturers, particularly in terms of clinical evaluation.

Even after the transitional period, and under certain conditions, manufacturers may continue to place on the market until May 2024 products compliant with the Directives, and distributors may continue to make them available or put them into service until May 2025.

Key Resources

Related Resources

This is a list of the most recent relevant documents from the Library. For more, filter through our database by clicking on the View More button below.

Release Date : 31 May 2018 | Country : European Union | Language : English

This newsletter from the European Hospital and Healthcare Federation contains an article on a survey related to the introduction of the MDR and IVDR conducted among 169 professionals working in medical device and IVD firms.

Release Date : 30 April 2018 | Country : European Union | Language : English

This newsletter from the European Hospital and Healthcare Federation contains an article on a communications campaign by the Commission related to the introduction of the MDR and IVDR.

Release Date : 9 November 2017 | Country : European Union | Language : English

This MedTech Europe Position Paper on Article 50 Negotiations between the European Union and the United Kingdom discusses what this process will mean with regards to the new Regulations.

Release Date : 9 March 2017 | Country : European Union | Language : English

This presentation from a Commission/CAMD stakeholder meeting on the revision of the EU medical devices legislation presents the main features of the new texts and some key aspects towards implementation.

Release Date : 21 March 2018 | Country : International | Language : English

This presentation, made at the International Medical Device Regulators’ Forum, provides a US Food and Drug Administration Working Group update on good regulatory review practices.

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