Commission proposals threaten to "slow innovation", says EDMA
Monday 22 September 2008 Amanda Maxwell - Editor, European Regulatory Affairs

Don't throw the spanner in just yet Photo: Linusb4

Many of the proposals in the European Commission's consultation paper on the recast of the medical device directives would lead to a substantial increase in the cost of regulation, both to the device industry and to regulators. These costs would not be justified and would damage the ability of companies - particularly SMEs - to develop the new products that patients and society in general need, writes Amanda Maxwell.

That is the response of the European Diagnostic Manufacturers Association (EDMA) to the European Commission's provocative consultation paper which opens up for debate many possible different avenues of regulation for medical devices, the deadline for comments on which was July 2.

EDMA asserts that if the Commissionís proposals were enacted, the likely result would be to 'slow innovation and even to make unviable the development and introduction of a significant number of new device products'.

These are amongst the detailed comments made public by EDMA ahead of the publication by the European Commission of its summary of comments made, due over the next month or so. They have been made as responses are beginning to flow in showing that there is a clear sense of shock and resistance to what the Commission has opened up for debate.

EDMA describes itself as 'greatly surprised and concerned' at the timing of the consultation. This is particularly so because it makes reference to a series of documents, such as the revision of the New Approach and the GHTF IVD classification guidelines which had not been published at the time when the consultation was initiated.

Moreover, the revision of the MDD and the AIMD has not yet been implemented, and the lack of the full operation of the key tool, the Eudamed medical device database, make it impossible to assess what the impact that review will have on the regulatory framework.

Don't fix it if it ain't broke

This regulatory framework has been successful in maintaining the necessary balance between ensuring that only products which meet prescribed safety and performance requirements for the benefit of public health are marketed, while at the same time allowing for a competitive and innovative environment for manufacturers.

That is not to say that improvements cannot be made to the current system, EDMA says. However it is important to recognise that the shortcomings must be evaluated against the overall success of the regulatory framework.

Most of the shortcomings which have arisen are not due to issues within the regulatory framework itself, but to the fact that certain aspects of the regulatory framework have not been implemented or not been fully implemented as intended.

The most obvious example of this is the failure, EDMA says, to implement Eudamed, as intended. This databank plays a pivotal role at the level of notification of devices and also at the level of exchange of information in post-market activities. "It is therefore advisable to understand why this and other provisions such as those agreed in MEDDEV guidance documents have not been implemented as intended before trying to seek novel solutions which could flounder if the fundamental problems have not been addressed," the association says.

"We believe that the concept of third party conformity assessment bodies, such as notified bodies, are an essential element of the new approach and should be maintained, although we agree that certain measures can be taken to enhance the system."

EDMA response to specific questions

Why reinvent the wheel? Photo: Lajla Borg Jensen

The EDMA document just published is 27 pages long and contains specific replies to the questions listed by the Commission in its consultation paper.

In response to one of the most controversial proposals from the Commission, that of creating a central agency to deal with given matters, EDMA feels that any such development in the field of IVDs is unnecessary since adequate provision exists within the current IVD regulatory system for this to be done - although they have not as yet been fully implemented as intended by the IVD Directive.

In EDMA's view it is critical, in order to prevent the need for such an agency, that:

• that the Eudamed dataset is established allowing for appropriate information to be recorded and exchanged regarding post-market surveillance and vigilance;

• that if it is perceived that there is a need for consultative scientific bodies, that an independent scientific committee, such as that already envisaged under Article 7 of the Medical Devices Directive and under the IVD Directive to advice the Commission on technical matters, would be more in line with the current regulatory framework and of maintaining the New Approach;

• and the difficulty of notified body oversight needs addressing. Ideally, the solution would be a truly active and responsive oversight group of designating authorities dealing with setting appropriate designation criteria, working rules and a harmonized implementation of these rules by all notified bodies. NBOG is already making progress in this direction.
  

Among the other statements that EDMA makes in its replies are the following:

• EDMA strongly recommends keeping the IVD Directive as a separate legislative text, and not merging it with the Medical Devices Directive and the Active Implantable Medical Devices Directive;

• EDMA is in favour of the adoption of a rules based risk classification which will in the long term be beneficial to all stakeholders as long as: such a system is adopting the rules based risk classification system as developed globally in GHTF....

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