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Eucomed Pleased with EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices

Eucomed Press Release Welcomes the EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices


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.

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

The Commission Staff Working Document provides some background 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 says: “As an immediate response to the PIP” (Poly Implant Prothèse Company) “crisis” (fraudulently made breast implants)”, the Commission, in February 2012, took the initiative of agreeing with the Member States a Joint Plan for Immediate Actions aimed at tightening controls and at restoring patient confidence in the regulatory system on the basis of existing legislation, pending the adoption by the co-legislator of the new legislation and its subsequent entry into application. 

Two years after the launch of the Joint Plan, this Commission Staff Working Document communicates the achievements of the plan. It also proposes some aspects that should be continued and intensified.” 

The press release from  Eucomed 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…”

Serge Bernasconi, Eucomed CEO said “The Action Plan very much reflects our recommendation to implement a ‘reinforced control procedure’ rather than turning the system on its head with a complex, costly and overly bureaucratic measure like the ‘scrutiny procedure’ contained in the Commission’s initial proposal and the European Parliament’s first reading agreement.”

In conclusion of the press release Eucomned goes on to say: “Eucomed also welcomes the Commission’s 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’s 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’s emphasis on these points will serve as inspiration to the Council as it continues negotiations towards its position.'”

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.

Substantial progress has until now been made in the implementation of the plan. In particular the following achievements can be noted:

    • Member States have re-assessed the qualifications of the notified bodies in charge of assessing high-risk devices, thus the vast majority of notified bodies. Member States have, in many cases, modified the scope of the activities of the notified bodies;
    • A majority of Member States have requested their notified bodies to carry out unannounced audits and have asked notified bodies to ensure they are informed about incident reports. Notified bodies have reported that they are in the process of launching the unannounced audits; 
    • Joint audits of notified bodies by teams involving auditors from several Member States and the Commission (FVO) have until May 2014 been carried out in 22 out of 23 countries having notified bodies and is scheduled for the remaining. The voluntary joint audits have been judged as very useful by all parties involved; 
    • Two Commission measures, respectively to ensure a consistent application of the criteria to be met for the designation of notified bodies and on the items to be verified by the notified bodies during an audit were adopted in September 2013. The first of the two measures has made the joint audits mandatory for new designations and re-designations of notified bodies. Five such audits have been carried out until April 2014. About 20 mandatory joint audits are foreseen for 2014; 
    • Most Member States have reported on their market surveillance activities. This information is used as a base for assessing the need for further improvement; 
    • Monthly vigilance teleconferences with Member States, chaired by the Commission services, have been launched and become regular. The teleconferences have proved to be a very efficient means of ensuring/improving coordination between Member States; 
    • The Commission Joint Research Centre (JRC) has started a metadata analysis in the field of vigilance reporting and is conducting a screening of publicly available sources with regard to the safety of medical devices relevant for the European Market;
    • A Commission Recommendation on the use of a specific system for traceability of medical devices (UDI) was adopted in April 2013; 
    • Dialogues with Member States are on-going on product registers; 
    • With regard to incident reporting from medical practitioners and patients, Member States however prefer to develop systems at national level.

The positive progress in the implementation of the plan has been discussed between Health Ministers in several EPSCO Councils.

Many Member States and stakeholders have underlined the importance to continue and intensify the work on certain aspects of the Joint Plan. The focus should be on problematic issues identified during the implementation of this plan that are not yet resolved, such as:

    • Market surveillance

The information received under the Joint Plan and the national market surveillance programmes indicate great divergences between the Member States with regard to resources attributed and how market surveillance is carried out. Many Member States recognise that because of a shortage of resources, market surveillance is only reactive and that no proactive surveillance is carried out.

These differences in approaches influence decisions on which products are concretely checked and on which aspects they are checked. Experience has shown that national competent authorities sometimes react in different ways to the same problems. A consequence is that whilst in some Member States the placing on the market or putting into service of a given device is banned or restricted, it may freely circulate in other Member States.

Some of the 20 actions for safer and compliant products for Europe outlined in a Commission communication of last year can be a source of inspiration for the concrete actions to be undertaken, in order to address those issues and to develop best practices (for example, a best practice would be to develop a common understanding of market surveillance and better co-ordination and communication on surveillance data, as set out in paragraph 3 of that Communication).

On the international level, the activities carried out within IMDRF could contribute to an increased coordination.

    • Functioning of notified bodies
The Joint Plan has led to the establishment of a new structure for the designation and supervision by Member States of notified bodies. Also guidance to notified bodies in their performance of audits and assessments has been given through a Recommendation. Assessment standards should also be improved through the own measures taken by many of the notified bodies in the Team NB framework.

There are clear signs of the positive effect of these measures, justifying the continuation of these efforts.
    •  Communication and transparency

The next steps on UDI and reporting of incidents from healthcare professionals are foreseen to be taken following the adaption of the new legislation.

The work on making best use of registers for providing data and identifying problems with devices that has been launched under the Joint Plan should be pursued under the current PARENT Joint Action and in follow up actions envisaged.

The proposals of the JRC project on identifying and developing recommendations for mechanisms to detect signals, trends and increased incident frequency more effectively should allow reducing the number of problems at the source and thus more effectively allocate the scarce resources attributed to market surveillance and vigilance. The results, that should become available mid-2014, should allow for discussions with Member States and stakeholders on the improvements in this respect.

    •  Sharing of knowledge and good practices
The actions undertaken under the Joint Plan have demonstrated the value of sharing knowledge and best practices between Member States. The experiences of the joint assessments of notified bodies have been very positive in this respect. In this context a joint training has been undertaken and more are foreseen. It could be beneficial to make use of this practice of joint training in other fields of activity.

The measures described above can all be undertaken under the framework of the Joint Plan and within the existing legislation. For other important aspects, it is not possible under the current legal provisions to reach the desired objectives.

Therefore the proposed new Regulations contain provisions which aim to solve in particular the problems relating to:
    • the scope of the legislation,
    • the governance of the system and its transparency,
    • certain obligations of notified bodies, in particular in relation to mandatory unannounced audits,
    • clinical evaluation,
    • the risk classification of devices and the safety and performance requirements,
    • obligations of economic operators,
    • reporting of incidents by users and patients to the Competent Authorities,
    • certain aspects relating to vigilance system and market surveillance,
    • the role and the functioning of the database Eudamed and the access of notified bodies to Eudamed, and
    • the traceability of devices.
Each of these points is pivotal towards ensuring patient and consumer safety and restoring confidence in the regulatory framework.

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at Leo at EisnerSafety dot com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).