European Authorized Representative | EU Regulatory Affairs

An Authorized Representative, MDSS is the main contact for the European Commission, National Competent Authorities, and is your EU Authorized Address. AboutMDSSMDSS SuperiorAuthorizedRepresentativeServices andYourBestEUAuthorizedAddress. AnAuthorizedRepresentative,MDSSisthemaincontactfortheEuropeanCommission,NationalCompetentAuthorities,andisyourEUAuthorizedAddress.Foundedin1995,MDSSpioneeredEuropeanRepresentation,andiswellknownandrespectedwiththeCompetentAuthorities.AsyourEUAuthorizedRepresentative,MDSShandlessensitivetaskswithintheCompetentAuthoritywithintegrityandperfection,whichenablesustoachievethebestsolutionsforyou. AppointingMDSSasyourEuropeanAuthorizedRepresentativewillliftyourcompanytotheforefrontofEuropeanRegulatoryRequirements. MDSSspecializesinEuropeanRegulatoryAffairs;and,asyourAuthorizedRepresentativeMDSSoffersyouafirst-classEUAuthorizedaddressintheEU. OurServicesAsYourEuropeanAuthorizedRepresentative,MDSSisresponsibleforyourproductsinEurope Ourservicesareanextensionofyourqualitysystem,fulfillingyourregulatoryobligationsinEurope. MedicalDeviceDirective(MDD)93/42/EECActivelmplantableMedicalDeviceDirective(AIMDD)90/385/EECInVitroDiagnosticMedicalDeviceDirective(IVD)98/79/ECMedicalDeviceRegulation-MDR(EU)2017/745In-VitroDeviceRegulation-IVDR(EU)2017/746Ourclients MDSSservesboththe MedicalDevice andthe InVitroMedicalDiagnostic industriesworldwide.OurdistinguishedclientsaresuccessfulintheirlocalmarketplaceandhaveexpandedtheirexpertiseintotheEuropeanarenawithMDSSastheirRegulatoryPartner. MDSSestablishesrespectandmutualconfidencewithclientstogetthebestresults.ThecombinedexpertiseofourclientsandMDSSformsalliances,whichensuressuccessinthemarketplace. MDSSProvides MDSS’uniqueprofessionalexpertiseonRegulatoryAffairsofCEMarkingforyourMedicalDevicesincludes: AuthorizedEuropeanAddress–yourfirstclassaddress RepresentationofourclientstotheEuropeanCommissionandNationalCompetentAuthorities ProductVigilancewithIncidentreportingandAdvisoryNotices RegistrationofyourproductswiththeEUAuthorities Verificationonproductclassification AssistancewithConformityAssessmentProcedures AssistancewithQualityAssuranceSystems(ENISO9001,ISO13485…) SafetyOfficerforGermanyandotherapplicablestates AdviseontechnicaldocumentationwithEssentialRequirements,RiskAnalysisandLabeling DeclarationofConformity UpdatesonEuropeanRegulatoryAffairsandidentifyingcompliancestrategies TheSignificanceofthebestRepresentation MedicalDevicecompaniessituatedoutsidetheEuropeanUnionmustdesignatean “AuthorizedRepresentative” inordertofulfillcertainrequirementsundertheEuropeanMedicalandInVitroDiagnosticDeviceDirectives. TheAuthorizedRepresentativeisthemaincontactfortheEuropeanCommissionandtheNationalCompetentAuthorities.TheManufacturerisrequiredtoprovideaccesstotheTechnicalDocumentationandmustincludetheaddressoftheAuthorizedRepresentativewiththeproduct. AppointingMDSSasyour EuropeanRepresentative willeffectivelyputyourcompanyontheforefrontofEuropeanRegulatoryRequirements.MDSSpioneeredEuropeanRepresentation. MDSSiswellknownandrespectedwithCompetentAuthorities,whichenablesustoachievethebestsolutionswithyourinterestsinmind.WehandlesensitivetaskswiththeCompetentAuthoritywithintegrityandperfection. TheTeamofMDSShasacomprehensiveknowledgebasedonsignificantRegulatoryandIndustryexperience.OurteamincludesPhysicians,Engineers,andLaboratoryTechnologists,dedicatedandhighlymotivatedtoprovidethebestcustomerserviceforourclients. Independentlyoperated,MDSSavoidsanyconflictofinterest,inregardstoorconcerningconfidentialtradeandproductinformation. MDSSsuccessfullyimplementedacomprehensivequalitysystemcertifiedtotheparticularmedicalrequirementsofDINENISO13485.MDSSwasrevieweddistinctivelyontheaspectoftheAuthorizedRepresentativeandreceivedacertificateon“authorizedrepresentation”inaccordancewithall MedicalDeviceDirectives. MDSSstandsforcontinuityandsafetythroughouttheEuropeanCommunitywithexperienceandstability. MDSSGmbH isamemberofthe EuropeanAssociationofAuthorizedRepresentatives(EAAR) andcertifiedinaccordanceto ISO13485. X