IMPLEMENTING THE NEW MEDICAL DEVICES REGULATION: INDUSTRY CALLS FOR SOLUTION TO ENSURE CONTINUITY OF CARE TO PATIENT

MDD REGULATION TRANSITION TIME - STOP THE CLOCK (?)

MedTech Europe -  Original publisher

MedTech Europe is calling on the European Commission, European Parliament and all EU Member States, to have an urgent discussion of solutions that will ensure that there is appropriate time for the systems to be ready to function. The industry calls for:

• Actions to address challenges on the transition timing

Industry envisages at least three options to be explored either alone or in combination:

a) A ‘stop the clock’ mechanism, that freezes the remaining transition time for both regulations until full readiness of the system has been achieved;

b) An extension of the critical dates of 26 May 2020 and 26 May 2022, for all products;

c) An extension of the critical dates of 26 May 2020 and 26 May 2022, for legacy products only.

Options b) and c) would require a specific timeline to be agreed upon.

• Actions to make the ‘grace period’ an effective instrument and overcome the bottlenecks These could include, for example:

a) Extending its scope to include all products and particularly the legacy products;

b) Having a more feasible and flexible timing.

MedTech Europe is ready to cooperate with the EU institutions and all affected stakeholders to identify and deliver an optimal way forward. We urge all concerned parties in the strongest possible terms to act now, in the interest of patients and industry alike.

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LE ISTITUZIONI EUROPEE IN 10 PUNTI - PUBBLICAZIONE GRATUITA

ISBN 979-12-200-1080-1

L’appartenenza all’Unione Europea comporta il rispetto di regole europee che sono gerarchicamente superiori, immediatamente dopo la costituzione repubblicana, alle leggi nazionali.

La gerarchia delle leggi indica i criteri di precedenza da seguire per il rispetto di esse.

Una conoscenza minima di base delle istituzioni europee, dei principi di formazione delle leggi e della loro valenza gerarchica aiutano gli operatori del sistema degli affari regolamentari a comprendere meglio il collocamento delle Direttive e Regolamenti che prescrivono i criteri di sicurezza in ambito marcatura CE nel panorama tecnico-normativo cogente e volontario. 

La pubblicazione scaricabile gratuitamente dal link sottostante, fornisce elementi minimi di base sulle istituzioni europee, sulla gerarchia delle fonti europee e italiane a coloro che non hanno alcuna conoscenza o esperienza in ambito tecnico-normativo.

Un approccio semplice e sintetico per acquisire una base di conoscenza che permetta a chi ha ruoli aziendali di responsabilità di affrontare le questioni del mercato europeo in relazione agli obblighi sui dispositivi medici.

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MEDICAL DEVICES AND VITRO IN DIAGNOSTIC MEDICAL DEVICES REGULATION The European Parliament is expected to adopt the two regulations in April, after which they will be published in the Official Journal

From

WebSite

The recent scandals related to metal-on-metal artificial hips or faulty silicone breast implants have strengthened the case for modernising current rules for medical devices.

On 7 March 2017, the Council adopted new EU rules improving the safety of medical devices for the benefit of patients while preserving a timely access to innovative healthcare solutions.

The two new EU regulations (MDD & IVDMDD):

-provide a stronger mandate to independent notified bodies in their assessment of medical devices before they can be placed on the market, and strengthen the oversight of these bodies by national authorities; the new rules also ensure that notified bodies meet the same high safety standards throughout the EU; these measures will improve the safety of medical devices;

-improve the availability of clinical data on devices and clearly set out manufacturers' responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; this will allow manufacturers to react quickly in the event of concerns being raised and help them improve their devices continuously on the basis of actual data;

-improve the traceability of medical devices throughout the supply chain to the end-user or patient by using a unique identification number; this will allow fast and effective measures to be taken in the event of safety problems;

-set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; this will enable them to make better informed decisions.

Go to European Council

Council of the European Union web page for more information>Click Here 

LE ISTITUZIONI EUROPEE IN 10 PUNTI - PUBBLICAZIONE GRATUITA

ISBN 979-12-200-1080-1

L’appartenenza all’Unione Europea comporta il rispetto di regole europee che sono gerarchicamente superiori, immediatamente dopo la costituzione repubblicana, alle leggi nazionali.

La gerarchia delle leggi indica i criteri di precedenza da seguire per il rispetto di esse.

Una conoscenza minima di base delle istituzioni europee, dei principi di formazione delle leggi e della loro valenza gerarchica aiutano gli operatori del sistema degli affari regolamentari a comprendere meglio il collocamento delle Direttive e Regolamenti che prescrivono i criteri di sicurezza in ambito marcatura CE nel panorama tecnico-normativo cogente e volontario. 

La pubblicazione scaricabile gratuitamente dal link sottostante, fornisce elementi minimi di base sulle istituzioni europee, sulla gerarchia delle fonti europee e italiane a coloro che non hanno alcuna conoscenza o esperienza in ambito tecnico-normativo.

Un approccio semplice e sintetico per acquisire una base di conoscenza che permetta a chi ha ruoli aziendali di responsabilità di affrontare le questioni del mercato europeo in relazione agli obblighi sui dispositivi medici.

Link download gratuito testo pdf

GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC – MEDDEV 2.7/1 revision 4 – june 2016

EUROPEAN COMMISSION DG 

Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies 

Health technology and Cosmetics

ABSTRACT

1. Introduction 

Pursuant to 

- section 6a of Annex I to Directive 93/42/EEC (amended by Directive 2007/47/EC) and to 

- section 5a of Annex 1 to Directive 90/385/EEC (amended by Directive 2007/47/EC), 

the demonstration of conformity with Essential Requirements for a medical device must include a clinical evaluation, which is conducted in accordance with Annex X to Directive 93/42/EEC or with Annex 7 to Directive 90/385/EEC. 

This document promotes a common approach to clinical evaluation for medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. 

The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question. Therefore, this guidance is not intended to impose device-specific requirements. 

This document uses the terms "must", "shall", "have to" where these terms are used in the Directives. "Should" is used in other instances. 

2. Scope 

This guide is not legally binding; only the text of the Directives is authentic in law. It is recognised that under given circumstances, for example as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements. Nevertheless, due to the participation of interested parties and of experts from national Competent Authorities, it is anticipated that this guide will be followed within the Member States, thereby supporting uniform application of relevant provisions of EU Directives and common practices.

On certain issues not addressed in the Directives, national legislation may be different from this guide. 

This guide is regularly updated according to regulatory developments. The latest version of the guide should always be used. This version is a complete revision of the previous texts. 

The medical device legislation in Europe is currently being significantly revised. A new Regulation of the European Parliament and of the Council on medical devices will be published, which may result in changes to important concepts or definitions relating to clinical evaluation. Parts or all of this document are likely to be revised. Some contents (such as contents about notified bodies) are likely to be removed and integrated in other series of documents. 

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NEW PERSONAL PROTECTIVE EQUPMENT REGULATION (EU) 2016/425

As of 21 April 2018, Directive 89/686/EEC will be repealed by the new Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment.

The new PPE Regulation is aligned to the New Legislative Framework policy. In addition it slightly modifies the scope and the risk categorisation of products. It also clarifies the documentary obligations of economic operators.

Entry into force and application 

"This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 

This Regulation shall apply from 21 April 2018, with the exception of: (a) Articles 20 to 36 and Article 44, which shall apply from 21 October 2016; (b) Article 45(1), which shall apply from 21 March 2018. This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Strasbourg, 9 March 2016." 

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LE ISTITUZIONI EUROPEE IN 10 PUNTI - PUBBLICAZIONE GRATUITA

ISBN 979-12-200-1080-1

L’appartenenza all’Unione Europea comporta il rispetto di regole europee che sono gerarchicamente superiori, immediatamente dopo la costituzione repubblicana, alle leggi nazionali.

La gerarchia delle leggi indica i criteri di precedenza da seguire per il rispetto di esse.

Una conoscenza minima di base delle istituzioni europee, dei principi di formazione delle leggi e della loro valenza gerarchica aiutano gli operatori del sistema degli affari regolamentari a comprendere meglio il collocamento delle Direttive e Regolamenti che prescrivono i criteri di sicurezza in ambito marcatura CE nel panorama tecnico-normativo cogente e volontario. 

La pubblicazione scaricabile gratuitamente dal link sottostante, fornisce elementi minimi di base sulle istituzioni europee, sulla gerarchia delle fonti europee e italiane a coloro che non hanno alcuna conoscenza o esperienza in ambito tecnico-normativo.

Un approccio semplice e sintetico per acquisire una base di conoscenza che permetta a chi ha ruoli aziendali di responsabilità di affrontare le questioni del mercato europeo in relazione agli obblighi sui dispositivi medici.

Link download gratuito testo pdf

REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 27 APRIL 2016 ON THE PROTECTION OF NATURAL PERSONS WITH REGARD TO THE PROCESSING OF PERSONAL DATA AND ON THE FREE MOVEMENT OF SUCH DATA

REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance) 

Entry into force and application 

1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 

(published on 4 May 2016)

2. It shall apply from 25 May 2018. 

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