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serves clients' specific needs with changes
of products and regulations.  Each client is unique and MDSS customizes the solution for each client individualy.

By: Ludger Möller

REGULATORY NEWS and VIEWS III

MDSS is continuously striving to provide the best possible service to our clients. Increasing client satisfaction is one of our most important objectives.

Content:

1. Guidelines Updates
2. RAPS Conference Spain Updates
3. Competent Authority - Experience Report
4. Traceability of Products - Experience Report
5. ISO 9001
6. Contacting MDSS - Survey - Contact Update- Hard and Software Upgrades

1. Guidelines Updates

We at MDSS feel it is our responsibility to provide updates regarding European regulatory affairs concerning medical devices to further support your regulatory presence in Europe. In view of this, it is our pleasure to forward the latest revisions of Medical Devices - Guidance Documents. Please find enclosed the following documents with the compliments of MDSS:

• * MEDDEV 2.12-1 rev. 4, Guidelines on a Medical Devices Vigilance System
• * MEDDEV 2.14/1 rev. 8, Guidelines for the Classification of Medical Devices

MDSS provided the draft version of the Vigilance guideline to you last year. At that time we pointed out the significant changes to the previous revision.

The Vigilance Guidelines are important in regards to your vigilance efforts in Europe and should be utilized when procedures and processes are being updated. Some companies will find it necessary to update their vigilance procedure based on this document alone. Please keep in mind that this document is a guideline, which provides interpretation of the requirements of the Medical Device Directive. Please contact MDSS if you have questions or need further clarification regarding this matter.

2. RAPS Conference Spain Updates

MDSS visited the European RAPS Conference in Spain this year. There are two significant updates we would like to inform you about.

1. A proposal to reclassify implants such as hip and knee implants to risk class III. The MDA of the UK is taking the lead in this area. However, to do so, the Medical Device Directive will need to be updated and this process will certainly take a few years.
2. The Data Protection Directive can be expected to further influence the exchange of patient/user information. Certainly, this will have an impact on the future exchange of information between MDSS and its international clients. Patient data received by MDSS may only be forwarded with the approval of the patient. MDSS handles such information very carefully due to its sensitive nature. We are evaluating further the overall effect on the Vigilance requirements.

3. Competent Authority - Experience Report

The different European Competent Authorities are becoming more organized and are exchanging data concerning their vigilance efforts among themselves. Events within the last months show that so-called Competent Authority Reports are being issued within the European Competent Authority structure. Theoretically, a Competent Authority issuing such a report should lead the investigation by collecting and responding to questions from other Authorities. Furthermore, this Authority should be the only contact point for the manufacturer or the Authorized Representative. This procedure does not completely function yet in its entirety. On one occasion when such a report was issued, five other Competent Authorities contacted MDSS requesting further and certainly different information.

Please be aware the Competent Authority Reports are also being forwarded to other member countries of the GHTF group including the FDA in the US.

4. Traceability of Products - Experience Report

I would like to increase the awareness of implementing an agreement with your distributor concerning the traceability of your products distributed into Europe if you have not done so.

We experienced a case where a distributor was unable to locate products during a recall, which was conducted Europe-wide. In today’s regulatory environment, the manufacturer assumed that distributors would automatically take over such a responsibility. In this particular case it became obvious that distributors in certain European countries were not aware of the need to trace medical devices. Please be advised that a European distributor may not feel obligated to install an internal process for further tracing of your products. Without an intact agreement stipulating the responsibilities concerning traceability with your distributor, it may not be possible to locate products on the market. It was confirmed to MDSS that those aspects are the responsibilities of the Manufacturer to a certain extent. Therefore MDSS would like to emphasize the importance of such an agreement. We strongly recommend an internal evaluation of the resulting regulatory consequences of this matter. Such an agreement should take the risk of products into consideration. Please contact MDSS for further details in setting up such an agreement.

 5. ISO 9001: 2000

As always, a few words regarding the new ISO 9001:2000 standard:

By now everyone knows that the ISO 9000 standard was updated in December 2000. There is still some confusion regarding the updates of the medical quality system standards EN 46001 and ISO 13485, which were based on the old version of ISO 9001:1994. An update of the ISO 13485 is not expected before 2003. Furthermore, it might become a stand-alone-standard not referencing the ISO 9001. It will be a standard used to fulfill statutory regulatory requirements. At that point, the European standard organization most likely will incorporate the ISO 13485 by harmonizing it to EN ISO 13485. EN 46001 most likely will become obsolete. The main reason for mentioning this in this newsletter is to increase the awareness of the upcoming issues during the transition period. The update of ISO 13485 might not be available when the transition period for the ISO 9001 ends in 2003. We strongly urge all of our certified clients to contact their notified bodies to avoid any surprises at the end of the transition period. At this time there are different approaches on how to handle the changeover. If you need any support or further clarification do not hesitate to contact MDSS.

6. Contacting MDSS - Survey - Contact Update - Hard and Software Upgrades

Recently it came to our attention that e-mails sent to MDSS were not received (our service provider analyzed that the e-mail “backbone” located in the Connecticut area was not functioning and all e-mail in that area was not forwarded for a day). This of course was very disturbing. A smooth-flowing communication system with our clients is an absolute must. If you should experience that MDSS does not respond in 24 hours, please send information by other means (e-mail, fax etc.). MDSS and you, as our clients, must be able to react quickly and efficiently in critical situations. In order to analyze and evaluate our communication with you, we would like to ask you to complete the attached survey and return it to MDSS. We would also appreciate any comment or suggestions for improvement.

Due to some personnel changes at some companies within the last year, MDSS was not able to contact clients immediately. As a precautionary measure MDSS would like to have at least the data of two contacts stored in our databank. Please use the attached form to submit the contact information for updating purposes.

MDSS will be upgrading the computer system (hardware and software). The change will take place in the first week of December. Please make a note that e-mail might be down during this period.

MDSS - your European Regulatory Affairs expert - thank you for all your support in the past and look forward to serving you in the future!

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