Regulatory News and Views from MDSS

MDD - Medical Device Directive
IVD – In Vitro Medical Device Directive
EN – European Norm (harmonized standard if published in the official Journal of the EU)
EU – European Union
ISO – International Standard Organization
MDSS – Medical Device Safety Service GmbH

MDSS, the only Authorized Representative certified to EN ISO 9001: 2000,
EN ISO 13485: 2000.
MDSS was certified to EN ISO 9002: 1996 and EN 46002 previously. We updated our system to the new EN ISO 9001: 2000 and the EN 13485: 2000. Recently we passed the surveillance assessment and plan to update our certification to the new EN ISO 13485: 2003. Enclosed is a copy of the certificate for your vendor file.

European Union Update
On May 1, 2004, ten countries are scheduled to join the European Union. This is the biggest challenge Europe has faced since its establishment. The new member states are mostly eastern European countries, which were suffering under a totalitarian system not too long ago. After not even ten years of freedom for some countries they are able to join Europe. Someone may imagine the changes those countries went through during the last decade.

The principles of free movement of personnel, goods and capital have been achieved for Europe and will be fully applied by the candidates as well (there is a restriction on the free movement of people for another 7 years). Even though today these countries on an average are in good standing, there are major cultural, social and economic differences in certain regions with in a country and among the countries. However, it is expected that trade is going to increase for the better of all.

The concept of the free movement of goods means that products freely move throughout Europe if accepted (approved) in one country. The basis for member states to accept this concept was that the technical requirements for goods are the same for all. In the European Union this was achieved by implementing the directives with the minimum requirements acceptable to all. The result of this concept is the CE mark. The CE mark simply shows that the product complies with the specified requirements and therefore is allowed to move freely throughout the European Union. You may interpret that the CE mark is the product passport for Europe. The new candidates are in the process of implementing the directive requirements, the same way as other current member states have done previously. As you know, the directive is not a law in itself. It needs to be transposed into national law. Therefore, how they do it -meaning what form the law is going to take - is the choice of the member state. The implementation of the requirements will ensure the “free movements of goods” as well throughout the new member states. The CE marking is not only applicable for currently 15, but in a few days for 25 European countries. A tremendous opportunity fully developed with more than 450 million people and with at least a decent health care system everywhere that will be able to purchase good, reliable medical devices.

Some candidates implemented registration schemes for medical devices. We do not know whether those will disappear after they join the EU or after the implementation of the European databank. Certainly, the registration of in vitro diagnostic medical devices is expected in each separate country to continue until the Databank is in place. Therefore the MDSS system (software and hardware) was updated to take care of the additional product registrations. We do not expect the European databank to be functioning in 2004 which would allow us to register a product only once in one member state. Some of our clients already experienced the different registrations. The countries come up with all sorts of different forms and require different information. This will increase the workload and we would like to ask you to inform MDSS early on when targeting a new market.

There is always a challenge which is inherent to CE marking. The MDD provides for it in article 4 section 4. “Member states may require the information … to be in their national language”. As of today, we only have a few confirmation of what the candidates will require. Most likely information provided with a product must be in the national language. Even if exceptions will be allowed, product information for the lay person will have to be provided in the language of the user.
MDSS would recommend to carefully evaluating a specific market to make the most use of your resources. Some of the new markets are that small that it may be prohibitive for the cost of the translation and other expenses to target a specific local market. As soon as MDSS receives confirmation of a member state language requirement it will be posted on our website.

The Swedish and UK authority for medical devices have been combined with the drug authority in their particular country

	New Name and Address
Sweden	Medical Products Agency 'Läkemedelsverket' Medical Devices Box 26 SE-751 03 Uppsala, Sweden Phone: +46 181 746 00, Fax : +46 185 031 15
UK	UKMedicines and Healthcare products Regulatory Agency (MHRA) Hannibal House Elephant & Castle London SE1 6TQ, United Kingdom Phone: +44 207 972 8184, Fax: +44 207 972 8111

A complete list of Competent authorities can be found on the European web site. A link is provided on the MDSS website.

Germany:
The German law maker past a decree in 2002 about the vigilance requirements. It is called “Sicherheitsplan” (safety plan). So far Germany is the only country to our knowledge that transposed a European guideline and upgraded it to national law. The requirements are not new because they are known from the vigilance guideline. With publishing this law a common misunderstanding among the manufacturers and as well (German) Notified Bodies was clarified. The guideline talks about maximum time limits for reporting incidents. 10 days for incidents and 30 days for near incidents. Those time limits found their way in procedures in stipulating that the manufacturer has 10 or 30 days to report an adverse event. This is not correct. The directive specifies to report immediately and the guideline stipulates as soon as possible. In addition the guideline allows a maximum time of 10 or 30 days for investigating whether an event is reportable or the device in question was the cause of the incident. After the maximum time the manufacturer has to report the event even if it is not clear whether it is reportable. This certainly means, on the other hand, that if it is clearly determined that the event was an incident and the device was clearly the cause of the incident it needs to be reported immediately. An immediate reporting is required by all directives. A lot of procedures today do not reflect the requirements correctly. MDSS would like to ask you to review your own procedures accordingly.

Experience from the Field.
We have noticed a few things I would like to share with you. In the past with notifying the authority of any incidents we received only limited feedback. With filing the information with an initial and final report the case was closed in most instances. However, today the authorities ask for more detailed information and as well have increased their surveillance activities. For example, in the past, a report was closed by the authority when announcing that the manufacturer implemented a recall or some other corrective action as a consequence of an incident. Today the authority monitors the result of your corrective actions. We are required to forward the appropriate information to satisfy the authorities’ information needs. Please be aware of the increased paperwork.

Important Standard Update.
Instead of listing all the standards we changed our website in providing the link to the European Union sites which proved to be very reliable in updating its list with the most current standards. Please review for yourself the list for your product. Keep in mind using a standard makes compliance a lot easier. The directive “presumes” if you comply with a standard you are in compliance of that particular aspect of the regulation. The important changes are: EN 46001/2/3 have been suspended and EN ISO 13485/8 has been harmonized. This is of particular interest for companies exporting to Canada which requires the same standards. With having a Notified Body in place who as well can issue Canadian certificates will streamline the audit process.

The most important update from our point of view is the new EN 980. It includes a symbol for the Authorized Representative. Enclosed for your convenience is how MDSS would like to appear on the Label OR the Instruction OR the Outer Packaging. As well the standard includes a symbol for identifying the manufacturer. Other updates are mostly related to IVD manufacturers. Using the symbols will ease the translation obligations for the label. Unfortunately for the time being it is required to explain the new symbols in the instruction for use.

Last but not least I would like to emphasize one more time on the new Risk management standard

EN ISO 14971. Joy in her last update outlined the importance of that standard. Applying this standard is imperative because you will cover the most critical requirements in the essential requirements of the directive.
We received tremendous feedback on the seminar for the new Risk Management standard and therefore we plan to have at least one more location for this Seminar probably during the latter part of this year. We also were asked to provide en executive overview of the IVD directive for our IVD clients. I guess some would like to see their superior going to such a seminar. We consider having a second Seminar scheduled for IVD clients nearby the AACC. The planning reaches its final stages and you will be informed shortly.

Contact Updates
Please keep MDSS informed as soon as we are receive a new contact in your organization. Since we have been contacted in the past by the authority regarding our clients’ products it is simply not good professional practice if we are not able to locate a new responsible contact in an organization. The manufacturer looses valuable time when a detailed response for the authority is needed. Enclosed is a simple form for identifying the new contacts. If you are not quite sure whether MDSS has the right contacts on file for your organization simply send back the form.

As always, if you have any questions or would like to have further clarification regarding the above or any other aspect related to CE marking, please do not hesitate to contact us.

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