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Cosmetic Products in Europe

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EVENTS
Meet us!

MEDICA
November 18-21, 2019
Dusseldorf, Germany
Booth #10B05





CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

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Safety Officer and Vigilance


The German Medical Device Act (MPG §30) requires that the manufacturers of medical devices appoint a Safety Officer. This person is to take over the legally defined responsibilities within the established reporting system. The Safety Officer is expected to have a certain level of qualification.

The person responsible for placing medical devices on the European market (manufacturers, authorized representatives, importers) are obliged to document and assess all incidents occurring within the EU area and to initiate suitable corrective actions as well as to inform the authorities.

This so-called vigilance system must follow a defined procedure. The person responsible for this procedure is usually the safety officer.

With the introduction of the MDR in Europe and according to. Art. 13, a "responsible person for the regulatory compliance" with enlarged area of responsibility is now required. This requirement was until now only applicable at national level. According to the MDR, in small and medium size companies, this function can also be assigned to  to qualified subcontractors.

Thanks to the wide range of staff qualification, MDSS Consulting GmbH can offer the service of an external safety officer for a large amount of product areas. Additionally, we have long-term experience from our work as independent Authorized Representative for our non-European clients in the MDSS Group.

Our services cover the following areas:
  • Feedback of the market and its assessment
  • Risk assessment in case of  incidents
  • Assessment of complaints in regards to  their reportability
  • Correspondence with the Competent Authorities
  • Support with corrective actions and  recalls
  • Introduction and maintenance of a Vigilance system as well as implementation of necessary procedures

If you would like to receive further information about our services, we are here for you!