Slide background
Slide background




Factsheet for Manufacturers of Medical Devices and In-Vitro Diagnostic

ID 7854 | | Visite: 1573 | Documenti Marcatura CE UEPermalink: https://www.certifico.com/id/7854

Factsheet for Manifacturers of Medical Devices   In Vitro Diagnostic

Factsheet for Manufacturers of Medical Devices and In-Vitro Diagnostic

1. Factsheet for Manufacturers of Medical Devices
2. Factsheet for Manufacturers of In-Vitro Diagnostic Medical Devices

Medical Devices Regulation (2017/745/EU)

The new Medical Devices Regulation (2017/745/EU) (MDR) and the In-Vitro Diagnostic Medical Regulation (2017/746/EU) (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making. The new Regulations will create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers. In contrast to Directives, Regulations do not need to be transposed into national law. The MDR and the IVDR will therefore reduce the risks of discrepancies in interpretation across the EU market. Transitional periods are planned to smooth the application of the new Regulations. However, you should bear in mind that consultants, in-house professionals, and Notified Bodies will all get busier as the deadline draws closer.

Medical Devices Regulation (MDR) background The MDR will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD). The MDR was published in May 2017, marking the start of a three-year period of transition from the MDD and the AIMDD. During the transitional period the MDR will come into force gradually, starting with the provisions related to the designation of Notified Bodies and the ability of manufacturers to apply for new certificates under the MDR. The transitional period will end on 26 May 2020, the “Date of Application” (DoA) of the Regulation. From that date the MDR will apply fully.

To avoid market disruption and allow a smooth transition from the Directives to the Regulation, several transitional provisions are in place (Article 120). Some devices with certificates issued under the Directives (AIMDD/MDD certificates) may continue to be placed on the market until 27 May 2024 , and made available until 27 May 2025. During the transition phase, products certified under the Directives and products certified under the Regulation will coexist on the market. Both will have equal status under the law, and no discrimination in public tenders may take place.

In-Vitro Diagnostic Medical Regulation (2017/746/EU)

The IVDR will replace the existing In-Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). The IVDR was published in May 2017, marking the start of a five-year period of transition from the IVDD.

During the transitional period the IVDR will come into force gradually, starting with the provisions related to the designation of Notified Bodies and the ability of manufacturers to apply for new certificates under the IVDR.

The transitional period will end on 26 May 2022, the “Date of Application” (DoA) of the Regulation. From that point the IVDR will apply fully.

To avoid market disruption and allow a smooth transition from the Directive to the Regulation, several transitional provisions are in place (Article 110). During the transition phase, products certified under the Directive and products certified under the Regulation will coexist on the market. Both will have equal status under the law, and no discrimination in public tenders may take place.

EC 2018



Tags: Marcatura CE Abbonati Marcatura CE Regolamento Dispositivi Medici Regolamento DMD Vitro

Ultimi archiviati Marcatura CE

Regolamento INAIL PED
Mag 05, 2021 47

Regolamento certificazione PED - INAIL

Regolamento certificazione PED - INAIL 2020 L'INAIL ON 0100 è un organismo notificato per le direttiva 2014/68/UE PED. La direttiva 2014/68/UE è una direttiva di prodotto riguardante gli apparecchi a pressione emanata dalla Comunità Europea e recepita in Italia con decreto legislativo n. 26 del… Leggi tutto
Regolamento certificazione T PED   INAIL 2021
Mag 05, 2021 45

Regolamento certificazione T-PED - INAIL 2021

Regolamento certificazione T-PED - INAIL 2021 Certificazione in accordo alla direttiva 2010/35/UE T-PED Destinatari Fabbricante, proprietario o utilizzatore dell’attrezzatura Caratteristiche La direttiva T-PED (2010/35/UE) si applica alle attrezzature a pressione trasportabili (Apt), disciplinando:… Leggi tutto
FAQ NRMM 2021
Mag 03, 2021 60

Non-Road Mobile Machinery emissions - NRMM Guide | Update 2021

Non-Road Mobile Machinery emissions - NRMM Guide | Update 2021 CECE, January 2021 The purpose of this frequently asked questions (hereinafter ‘FAQ’) document is to contribute to a clear understanding of the Regulation (EU) 2016/1628, as amended by Regulation (EU) 2020/1040 (hereafter referred to as… Leggi tutto
Fig 1
Apr 30, 2021 69

Rettifica del regolamento (UE) 2020/740 | 30.04.2021

Rettifica del regolamento (UE) 2020/740 | 30.04.2021 Rettifica del regolamento (UE) 2020/740 del Parlamento europeo e del Consiglio del 25 maggio 2020 sull’etichettatura dei pneumatici in relazione al consumo di carburante e ad altri parametri, che modifica il regolamento (UE) 2017/1369 e che… Leggi tutto
Guidelines Regolations EU  n  811 812 813 814 2013
Apr 12, 2021 197

Guidelines Regulations (EU) n. 811-812-813-814/2013 and Regulations (EU) 2015/1187-1189

Guidelines Regulations (EU) n. 811-812-813-814/2013 and Regulations (EU) 2015/1187-1189 EC, 2018 The Ecodesign and Energy Labelling Regulations for space and water heaters were published in 2013 and for solid fuel boilers in 2015. The regulations establish minimum requirements and an energy… Leggi tutto
Mar 31, 2021 208

Rettifica del regolamento (UE) 2019/1020 | 31.03.2021

Rettifica del regolamento (UE) 2019/1020 | 31.03.2021 Rettifica del regolamento (UE) 2019/1020 del Parlamento europeo e del Consiglio, del 20 giugno 2019, sulla vigilanza del mercato e sulla conformità dei prodotti e che modifica la direttiva 2004/42/CE e i regolamenti (CE) n. 765/2008 e (UE) n.… Leggi tutto

Più letti Marcatura CE

Giu 26, 2019 65067

Regolamento Prodotti da Costruzione (UE) 305/2011 - CPR

Regolamento CPR (UE) 305/2011 Regolamento (UE) N. 305/2011 del Parlamento Europeo e del Consiglio del 9 marzo 2011 che fissa condizioni armonizzate per la commercializzazione dei prodotti da costruzione e che abroga la direttiva 89/106/CEE del Consiglio (Testo rilevante ai fini del SEE) GU L 88/10… Leggi tutto