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News and Views February 2017


•    Workshops – new Medical Devices Regulation
•    Clarification regarding Notified bodies being liable - European Court Decision
•    New Medical Device Regulation (MDR) close to be published




Dear Customer,
Dear Partner,

 
Workshops new Medical Device Regulation

MDSS was invited to conduct a two day workshop in Singapore and organized its first one day workshop in Anaheim CA concerning the new MDR.
 
We are thankful for the TUV Rheinland’s support with the Anaheim workshop which added value thru the exchange of information and interpretation from the notified body (NB) perspective. Special thanks to Mr. Balazs Bozsik as presenter and Keith Sinclair for being available to answer additional questions concerning the testing of medical devices.
 
Examples of the concerns raised at both workshops by the attendees:
  • Labeling: How to cope with the requirement that the Importer is required to place his name and address on the products? Will the importer require this already from the manufacturer?
  • Competent authority (CA) facilitating compliance information of the medical device to a potential injured patient, which they believe may have caused damage. What is meant by caused damage by the devices and what kind of information may be given in this context to whom?
  • Additional liability requirements for the manufacturer and the authorized representative (AR) raised the eyebrows in regards to the entity that may check on these aspects. Will the CA inspect manufacturer whether they have sufficient resources for compensating patients?
  • ARs are supposed to announce to the NB and the CA when they cancel the contract. This is not necessary a problem. However, with the obligation to terminate the contract if the manufacturer is not in compliance raised the question on how and when this can be determined by the AR?
 
There are a number of other controversial aspects which have to be resolved in regards to the right interpretations and courts may be involved on a number of those issues.
 
Due to the amazing feedback the workshops received, MDSS will provide additional workshops throughout the year at different locations.  We are thrilled that Clients offered to host the workshop for a particular region.  This will enable us to provide additional workshops in areas where it is conducive for others.  Please contact us if your company would like to host a workshop.
 
MDSS can also be engaged for a one or two-day workshop geared towards your own company requirements. The benefit for the company may be multiplied due to the specific aspect, which may be addressed and certainly the increased number of employees that can attend via an in-house program. Please contact us if your company would like MDSS to provide an in house workshop.
 
Clarification regarding Notified bodies being liable - European Court Decision

A German court of which TUV Rheinland is being exposed to due to the breast implant scandal now received further clarification via the European Court.  This court posed questions to them and they were answered in detail clarifying the obligation of the Notified body.  Among them, that the notified body is not required to perform unannounced audits on a regular basis.  This should help with the court rulings in Germany and France to come to final conclusions quickly.  This news and views cannot perform a legal review but the court ruling was not a surprise to us since there are “only” certain responsibilities and tasks given by the directive and someone having a role there should be measured and being liable accordingly.  Common Sense? Here you find the judgement:
http://curia.europa.eu/juris/celex.jsf?celex=62015CJ0219&lang1=en&type=TXT&ancre
With this clarification the national courts will have to decide further the liability under the national rules for the notified body TUV in regards whether they failed to perform under their obligations.
 
Learning from this case we may have to ask whether the manufacturers and ARs have to consider different liability rules in the various European countries?
 
New MDR close to be finalized

We hear everyday new aspects, changes and additions to the MDR.  Texts with corrections are floating around and the numbering has been updated.  The political agreement was reached, but a number of issues still need to be clarified.  Among them the transition period of certificates and the making available of product!  We recommend to immediately considering this once the MDR is published, in order to identify the date the “new CE Mark” must be applied with your products at the latest.
 
Thank you for the support you provide to MDSS that we can serve you better.

Please be alert for the MDSS News and Views.  More European updates are expected on shorter intervals.


Your MDSS Team