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  1. europa.eu › youreurope › businessCE marking – obtaining the certificate, EU requirements ...

    3 days ago · Learn how to obtain CE marking for your product sold in the EU, when you need to involve a notified body and how to affix the marking. Find out the rules by product category, the Nando database and the difference between CE marking and voluntary certificates.

    • Nando

      Notified bodies (NANDO) Notification is an act whereby a...

    • CE-merkintä

      Maksaako CE-merkintä? Jos valmistaja tekee...

  2. medenvoyglobal.com › performing-clinicalPerforming Clinical Evaluations: Article 61(10) Under the MDR

    4 days ago · Section J establishes special considerations for Notified Bodies during the assessments of clinical evaluations prepared under an Article 61(10) approach and serves as guidance for manufacturers preparing such reports to ensure that these considerations are addressed.

  3. www.gov.uk › government › publicationsImplementation of the future regulations - GOV.UK

    3 days ago · 1. Implementation of the future regulations. The government intends to introduce new regulations for medical devices that prioritise patient safety, give patients access to the medical...

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  5. www.eurofins.com › electrical-and-electronicsMatter Testing & Certification | Eurofins E&E

    5 days ago · Eurofins E&E laboratories operate as notified and certification bodies under a number of national and international schemes. As such, we can help you gain access to global markets including, but not limited to:

  6. www.jnjmedtech.com › en-US › eu-mdrEU MDR | J&J MedTech - Johnson & Johnson Medical Devices

    1 day ago · EU MDR brings more stringent requirements to review Technical Documentation for the designated Notified Bodies ; Restricted Substances, if applicable, and Device Lifetime will now appear on product labels, as well as a MD symbol and UDI barcode ; In some cases, these increased requirements may drive portfolio changes for medical device providers.

  7. www.gov.uk › government › publicationsUK approved bodies for medical devices - GOV.UK

    4 days ago · See the Approved Body’s full designated scope. INTERTEK MEDICAL NOTIFIED BODY UK Ltd (8532)

  8. www.inspec-international.com › certificationINSPEC International - Certification

    2 days ago · We are an Approved Body and a Notified Body under UK and EU legislation, respectively - providing services for UKCA, UKNI and CE product conformity schemes. We cover all types of PPE - from head to toe.