CENTRO DI DOCUMENTAZIONE SUI DISPOSITIVI MEDICI

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...

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 acqu...

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 ac...

The Rapid Alert System for non-food dangerous products facilitates the rapid exchange of information between   national authorities   of 31 countries and the European Commission on dangerous products found on the market. The Commission publishes a weekly overview of the alerts on products reported by the national authorities. They include information on the dangerous products found, the risks identified and the measures taken in the notifying country in order to prevent or restrict their marketing or use. Measures can be ordered by national authorities ("compulsory measures") or be taken directly by producers and distributors ("voluntary measures"). Each alert also includes information on the countries where the same product was found and further measures were taken. Updated to / Aggiornamento al  18/11/2016 Rapid Alert System – Weekly Notification reports LINK> REPORT RAPEX

The Rapid Alert System for non-food dangerous products facilitates the rapid exchange of information between   national authorities   of 31 countries and the European Commission on dangerous products found on the market. The Commission publishes a weekly overview of the alerts on products reported by the national authorities. They include information on the dangerous products found, the risks identified and the measures taken in the notifying country in order to prevent or restrict their marketing or use. Measures can be ordered by national authorities ("compulsory measures") or be taken directly by producers and distributors ("voluntary measures"). Each alert also includes information on the countries where the same product was found and further measures were taken. Updated to / Aggiornamento al  11/11/2016 Rapid Alert System – Weekly Notification reports LINK> REPORT RAPEX

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....

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 Strasbo...

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...

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.  Go to regulation> Click Here

Membership status Candidate country Background In 1987, Turkey applied to join what was then the European Economic Community, and in 1997 it was declared eligible to join the EU. Turkey's involvement with European integration dates back to 1959 and includes the Ankara Association Agreement (1963) for the progressive establishment of a Customs Union (ultimately set up in 1995). Accession negotiations  started in 2005, but until Turkey agrees to apply the Additional Protocol  of the Ankara Association Agreement to Cyprus, eight negotiation chapters will not be opened and no chapter will be provisionally closed. Turkey is seeing an unprecedented and continuously increasing influx of people seeking refuge from Syria which has exceeded 2.2 million to date. Overall, Turkey is the country in the world hosting the highest number of refugees, and has already spent more than 7 billion EUR of its own resources on addressing this crisis. The Commission has engaged with Turkey...

Membership status Candidate country Background The former Yugoslav Republic of Macedonia – along with other Western Balkans countries – was identified as a potential candidate for EU membership during the  Thessaloniki European Council  summit in 2003. The former Yugoslav Republic of Macedonia applied for EU membership in March 2004. The Commission issued a favourable opinion in November 2005, and the Council decided in December 2005 to grant the country candidate status. In October 2009, the Commission recommended that accession negotiations be opened.

Membership status Candidate country Background Serbia – along with 5 other Western Balkans countries – was identified as a potential candidate for EU membership during the Thessaloniki European Council summit in 2003. In 2008, a  European partnership for Serbia  was adopted, setting out priorities for the country's membership application, and in 2009 Serbia formally applied. In March 2012 Serbia was granted EU candidate status. In September 2013 a  Stabilisation and Association Agreement  between the EU and Serbia entered into force. In line with the decision of the European Council in June 2013 to open accession negotiations with Serbia, the Council adopted in December 2013  the negotiating framework  and agreed to hold the 1st Intergovernmental Conference with Serbia in January 2014. On 21 January 2014,  the 1st Intergovernmental Conference  took place, signaling the formal start of Serbia's accession negotiations. More information ...

Membership status Candidate country Background In 2006 Montenegro's parliament declared independence from the State Union of Serbia and Montenegro. In 2008, the new country applied for EU membership. In 2010, the Commission issued a  favourable opinion on Montenegro's application , identifying 7 key priorities that would need to be addressed for negotiations to begin, and the Council granted it candidate status. In December 2011, the Council launched the accession process with a view to opening negotiations in June 2012. The accession negotiations with Montenegro started on 29 June 2012. More information on the country's relations with the EU

Albania Membership status Candidate country Background Albania – along with other Western Balkans countries – was identified as a potential candidate for EU membership during the  Thessaloniki European Council   summit in June 2003. In 2009, Albania submitted its formal application for EU membership. In its Opinion on Albania's application (in 2010), the Commission assessed that before accession negotiations could be formally opened, Albania still had to achieve a necessary degree of compliance with the membership criteria and in particular to meet the 12 key priorities identified in the Opinion. In October 2012, Commission recommended that Albania be granted EU candidate status, subject to completion of key measures in the areas of judicial and public administration reform and revision of the parliamentary rules of procedures. In June 2014, Albania was awarded candidate status by the EU. More information on the country's relations with the EU

From website The European Commission provides a range of guidance documents to assist stakeholders in implementing directives related to medical devices. Guidance MEDDEVEs The MEDDEVs promote a common approach to be followed by manufacturers and Notified Bodies that are involved in conformity assessment procedures. The MEDDEVs are drafted by authorities charged with safeguarding public health in conjunction with all stakeholders; industry associations, health professionals associations, Notified Bodies and European Standardisation Organisations. This is in accordance with the relevant annexes of the directives MEDDEVs are carefully drafted through a consultation process with all interested parties and are subject to a regular updating process These documents have particular reference codes and are endorsed at the Medical Devices Expert Group (MDEG) plenary meetings The guidelines are not legally binding. However, due to the participation of the aforementi...