{"id":3921,"date":"2014-06-18T21:11:38","date_gmt":"2014-06-18T21:11:38","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3921"},"modified":"2014-06-18T21:11:38","modified_gmt":"2014-06-18T21:11:38","slug":"eucomed-pleased-with-eu-commissions-conclusions-on-joint-plan-for-immediate-actions-for-medical-devices","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2014\/06\/18\/eucomed-pleased-with-eu-commissions-conclusions-on-joint-plan-for-immediate-actions-for-medical-devices\/","title":{"rendered":"Eucomed Pleased with EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices"},"content":{"rendered":"

\"\"<\/a>Eucomed Press Release Welcomes the EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices<\/span><\/h4>\n

 <\/p>\n

This post is on the Eucomed Press Release is Pleased with the EU Commissions’s work on the Joint Plan for Immediate Actions for Medical Devices.<\/span><\/p>\n

On 18 June 2014 Eucomed released a Press Release<\/a><\/strong> about a document the EU Commission released on 17 June 2014. \u00a0The title of the document is “COMMISSION STAFF WORKING DOCUMENT Implementation of the\u00a0<\/span>Joint Plan for Immediate Actions under the existing Medical Devices\u00a0<\/span><\/a><\/strong>legislation”<\/a><\/strong>. \u00a0<\/span>Eucomed seems to be pleased with the EU Commission on the approach they are taking in this Joint Plan document. \u00a0In the press release Eucomed says: <\/span>“The Commission\u2019s assessment confirms that much needed improvements to Europe\u2019s notified body system have been successfully implemented and are already yielding tangible results.\u00a0 The Commission also outlines a series of remaining gaps in the system that it believes can only be appropriately addressed in the new Regulation.”<\/span> The<\/span>\u00a0document comes from the\u00a0Secretary-General of the European Commission and is addressed to the EU Council (Mr Uwe CORSEPIUS, Secretary-General of the Council of the European\u00a0<\/span>Union).<\/span><\/span><\/p>\n

The Commission Staff Working Document<\/a><\/strong> provides some backg<\/span>round about the history of why this occurred (the Joint Plan) and as Eucomed stated this document “outlines system improvements achieved thus far and highlights remaining gaps to be addressed in new Regulation”. The Commission Staff Working Document<\/a><\/strong> says: “As an immediate response to the PIP” (Poly Implant Proth\u00e8se Company) “crisis” (fraudulently made breast implants)”, the Commission, in February 2012, took\u00a0<\/span>the initiative of agreeing with the Member States a Joint Plan for Immediate Actions\u00a0<\/span>aimed at tightening controls and at restoring patient confidence in the regulatory\u00a0<\/span>system on the basis of existing legislation, pending the adoption by the co-legislator\u00a0<\/span>of the new legislation and its subsequent entry into application.\u00a0<\/span><\/span><\/p>\n

Two years after the launch of the Joint Plan, this Commission Staff Working <\/span>Document communicates the achievements of the plan. It also proposes some aspects\u00a0<\/span>that should be continued and intensified.”\u00a0<\/span><\/span><\/p>\n

The press release from \u00a0Eucomed some very positive comments such as: “The conclusions outlined in the….document reflect the collective feedback from Eucomed member companies that Europe’s notified body system is now subject to tightened controls with tangible results such as unannounced audits of manufacturers and notified bodies.” :”Eucomed…welcomes the Commussion’s concrete progress…”<\/span><\/p>\n

Serge Bernasconi, Eucomed CEO said \u201cThe Action Plan very much reflects our recommendation to implement a \u2018reinforced control procedure<\/a><\/strong>\u2019 rather than turning the system on its head with a complex, costly and overly bureaucratic measure like the \u2018scrutiny procedure\u2019 contained in the Commission\u2019s initial proposal and the European Parliament\u2019s first reading agreement.\u201d<\/em><\/span><\/p>\n

<\/em>In conclusion of the press release Eucomned goes on to say: “Eucomed also welcomes the Commission\u2019s clear delineation in the final pages of their report of the issues that are critical to a strengthened system and must be addressed in the new Regulation, including the obligations of notified bodies, clinical evaluation and vigilance. The European medical device industry also welcomes the Commission\u2019s reference to registries and looks forward to further dialogue on the topic. …Mr Bernasconi said, ‘…perhaps more importantly, in this document they have made clear where there is more work to be done. I am hopeful that the Commission\u2019s emphasis on these points will serve as inspiration to the Council as it continues negotiations towards its position<\/em>.'”<\/span><\/p>\n

Below is the conclusion section of the Commission’s Staff Working Document which is what Eucomed was praising in the conclusion of their press release.<\/span><\/p>\n

Substantial progress has until now been made in the implementation of the plan. In particular the following achievements can be noted:<\/span><\/p>\n