By: Ludger Möller

News and Views

October 2009

Content:
THE NEW DIRECTIVE
ITALIAN REGISTRATION

Dear valued Client,


The new Directive:
There was a great concern with MDSS that the update of the directive was not yet taken into consideration by our clients. In some cases there are major changes which need to be taken care of. In almost all cases changes will have to be implemented.

I was glad to hear from a number of clients at the recent RAPS meeting in the USA that our clients are prepared. Most of them had a solid plan in place, a few were done with the update. In order to cope with the requirements those clients visited various seminars and as well were in the RAPS session which provided further information.

The new directive will lead to a number of other changes within the regulation scheme. For example the guidelines as well the commission issued interpretation documents. In addition the member states have to transpose the directive in to the national laws. As already noted in the past the member states like to implement additional requirements. Most countries have transposed the directive. It will be applied by March 21, 2009.

MDSS provided in the past information and most of our clients know where to get the information but with this newsletter I would like to increase the awareness and also start a series of Newsletter discussing the various updates. Today we will provide simply some guidance where to get the information on the European website.

The starting point is here: http://ec.europa.eu/enterprise/medical_devices/index_en.htm
From that page all regulations on a European level can be found. It also provides links to other related regulation for your products.

Just a few other links for convenience:

The medical directive and all its updates can be found here. http://ec.europa.eu/enterprise/medical_devices/legislation_en.htm
The consolidated version which combines all updates is recommended for ease of reading.

The MEDDEV guidance documents can be found here: http://ec.europa.eu/enterprise/medical_devices/meddev/meddev_en.htm
The most recent update is for Borderline products. We will see that other guidance documents will have to be updated simply also to adjust them to the new directive.

A fairly new set of documents are the interpretative documents issued by the commission. They can be found here: http://ec.europa.eu/enterprise/medical_devices/guide-stds-directives/interpretative_documents_en.htm


MDSS will follow with shorter newsletters to provide further guidance or also some interpretative information. Also in view of the changes and its importance MDSS may also be hired to provide in house Seminars on specific subjects. Those may also be held via webcast.

The Italian registration:
This is just a reminder to take care of the registration if you have business in Italy. MDSS would be happy to support you further with taking care of the process for you.

We also would like to let you know that the European Commission started an initiative in regards to the Italian registration in questioning the Italian Government. This initiative was due to numerous complaints of the additional registration and cost. In our evaluation we fully agree with the complaints and in certain areas the European Commission may be successful but we do not believe that the registration will completely go away even if the European commission should be somewhat successful.

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