lufthansa-kreditkartenabrechnung The expiry of period laid down in point b paragraph shall be suspended from date first request until such time as additional information has been received. The notified body shall notify competent authorities authority responsible for bodies and Commission through electronic system referred to in Article of whether procedure paragraph this be applied

Spongebozz sftb

Spongebozz sftb

If the notified body finds a divergence between sample taken from devices produced or market and specifications laid down technical documentation approved design it shall suspend withdraw relevant certificate impose restrictions . Ionising radiation Devices intended to emit ionizing shall be designed and manufactured taking into account the requirements of Directive Euratom laying down basic safety standards for protection against dangers arising from exposure . The Sponsor shall complete followup of investigation subjects. Classification shall be carried out in accordance with Annex VIII. Manufacturers of class IIb and III devices shall update the PSUR least annually

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Ein schnupfen hätte auch gereicht

Ein schnupfen hätte auch gereicht

The information referred to first subparagraph shall be provided purpose of making it available particular patient who has been implanted with device by any means that allow rapid access and stated language determined concerned Member . The authority responsible for notified bodies together with joint assessment team shall plan and conduct onsite of applicant conformity body where relevant any subsidiary subcontractor located inside outside Union be involved process. The Commission may by means of implementing acts adopt measures setting out detailed arrangements and related documents for peer review mechanism training qualification referred to paragraph this Article. Where the manufacturer plans to introduce any of abovementioned changes it shall inform notified body which issued EU technical documentation assessment certificate thereof

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Steinpflanzen

Steinpflanzen

The same information shall be given moving parts and their housings where direction of movement needs to known order avoid risk. In the case of devices referred to first subparagraph Article quality safety and usefulness substance which if used separately would be considered medicinal product within meaning point Directive shall verified by analogy methods specified Annex required applicable conformity assessment procedure under this Regulation. Devices that are composed of substances or combinations intended to be introduced into the human body and absorbed by locally dispersed shall comply where applicable manner limited aspects not covered this Regulation with relevant requirements laid down Annex Directive for evaluation absorption distribution metabolism excretion tolerance toxicity interaction other medicinal products potential adverse reactions required conformity assessment procedure under . The procedures used to perform clinical investigation shall be appropriate device under . The UDI A shall be assigned to device itself or packaging. Software referred to in this Section that intended be used combination with mobile computing platforms shall designed and manufactured taking into account the specific features

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Kv hessen arztsuche

Kv hessen arztsuche

PART BCORE DATA ELEMENTS TO BE PROVIDED THE UDI DATABASE TOGETHER WITH UDIDI IN ACCORDANCE ARTICLES AND manufacturer shall of following information relating device quantity per package configuration Basic referred any additional UDIDIs manner which production controlled expiry date manufacturing lot number serial if applicable unit use where not labelled level its assigned so associate patient name address indicated SRN issued authorised representative medical nomenclature code risk class trade model reference catalogue clinical size including volume length gauge diameter description optional storage handling conditions instructions names singleuse maximum reuses sterile need sterilisation before containing latex Section. This Regulation also applies to clinical investigations conducted the Union concerning products referred first subparagraph. Devices shall be designed and manufactured in such way that exposure of patients users other persons to emission unintended stray or scattered radiation reduced as far possible. Eudamed shall include the following electronic systems for registration of devices referred to Article UDIdatabase economic operators notified bodies and certificates clinical investigations vigilance postmarket surveillance . The draft of summary safety and clinical performance shall be part documentation to submitted notified body involved conformity assessment pursuant Article validated by that

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Kvr munich

Kvr munich

Where necessary to ensure the uniform application of Annex XIV Commission may having due regard technical and scientific progress adopt implementing acts extent resolve issues divergent interpretation practical . The summary of safety and clinical performance shall include at least following aspects identification device manufacturer including Basic UDIDI already issued SRN intended purpose any indications target populations description reference to previous generation variants such exist differences well where relevant accessories other devices products which are be used combination with possible diagnostic therapeutic alternatives harmonised standards CS applied evaluation referred Annex XIV information postmarket followup suggested profile training users residual risks undesirable effects warnings precautions. In the light of technical progress Commission empowered to adopt delegated acts accordance with Article amending minimum content certificates set out Annex XII. In such case the clinical investigation plan referred to Section of Chapter II Annex XV shall specify when results are going be available together with justification

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Rtl videotext

Rtl videotext

The manufacturer shall give authorisation to notified body carry out necessary audits including onsite and supply with relevant information particular documentation quality management system any findings conclusions resulting from application of postmarket surveillance plan PMCF representative sample devices provisions vigilance set Articles data stipulated relating design such as results analyses calculations tests solutions adopted regarding riskmanagement referred Section Annex andthe control reports calibration records qualifications personnel concerned. All active devices intended to control or monitor the performance of therapeutic class IIb directly influence such are classified . Investigational devices shall be subject to the requirements set out Articles

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A Member State that permits reprocessing of singleuse devices may maintain or introduce national provisions are stricter than those laid down this Regulation and which restrict prohibit within territory the following transfer another third country view their making available further reprocessed . The characteristics and performance of device shall not be adversely affected to such degree that health safety patient user where applicable other persons are compromised during lifetime as indicated by manufacturer when subjected stresses which can occur normal conditions has been properly maintained accordance with instructions. For devices exclusively intended retail point of sale the UDIPIs AIDC shall not be required to appear on packaging