|
|
Compliance with essential safety requirements |
Due Diligence |
-
|
|
|
- Description:
- The manufacturer must ensure that products are designed and manufactured in accordance with the essential health and safety requirements when placed on the market or first used for its own purposes.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- New apparatus, protective systems, safety, controlling and regulating devices, and components within the scope of the Regulation.
- Checking responsibility:
- Manufacturer; verification by market surveillance authorities.
- Check method:
- Review of the technical design and manufacture against the essential health and safety requirements.
- Rule set:
-
-
- Source reference:
- § 5 Absatz 1
- Source excerpt:
- Der Hersteller stellt sicher, wenn er Produkte in den Verkehr bringt oder für eigene Zwecke erstmals verwendet, dass sie nach den wesentlichen Gesundheits- und Sicherheitsanforderungen nach Anhang II der Richtlinie 2014/34/EU in der Fassung vom 9. Oktober 2024 entworfen und hergestellt wurden.
|
|
|
Technical documentation and conformity assessment |
Approval |
-
|
|
|
- Description:
- The manufacturer must prepare the required technical documentation and complete the applicable conformity assessment procedure. After a successful assessment, it must issue an EU declaration of conformity and affix the CE marking for apparatus, protective systems, and safety, controlling and regulating devices; for components, it must issue a written certificate of conformity.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products placed on the market or first used for the manufacturer's own purposes.
- Checking responsibility:
- Manufacturer; where applicable, the notified body and market surveillance authority.
- Check method:
- Review of the technical documentation and completed conformity assessment procedure.
- Rule set:
-
-
- Source reference:
- § 5 Absatz 2
- Source excerpt:
- Der Hersteller darf Produkte nur in den Verkehr bringen oder für eigene Zwecke erstmals verwenden, wenn die technischen Unterlagen nach Anhang III Nummer 3 Buchstabe c, nach Anhang IV Nummer 3.1 Buchstabe e, nach Anhang VII Nummer 3.1 Buchstabe e, nach Anhang VIII Nummer 2 oder nach Anhang IX Nummer 2 der Richtlinie 2014/34/EU in der Fassung vom 9. Oktober 2024 erstellt wurden und das Konformitätsbewertungsverfahren nach § 13 Absatz 1 Satz 1 durchgeführt wurde.
|
|
|
Marking and product information |
Other |
-
|
|
|
- Description:
- The manufacturer must make products identifiable, affix the special explosion-protection markings, provide its name and postal address, and include operating instructions and safety information in German. Markings and information must be clear, comprehensible, and legible.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- All products of the manufacturer.
- Checking responsibility:
- Manufacturer; market surveillance authority upon request.
- Check method:
- Inspection of the product, packaging, or accompanying documentation for identification information, markings, contact details, and documents.
- Rule set:
-
-
- Source reference:
- § 6 Absatz 1
- Source excerpt:
- Der Hersteller hat dafür zu sorgen, dass seine Produkte beim Inverkehrbringen oder bei der erstmaligen Verwendung für eigene Zwecke eine Typen-, Chargen- oder Seriennummer oder eine andere Information zu ihrer Identifikation tragen.
|
|
|
Retention of conformity documents |
Record Keeping |
-
|
|
|
- Description:
- The manufacturer must keep the technical documentation and the EU declaration of conformity or certificate of conformity available to market surveillance authorities for ten years from placing the product on the market.
- Frequency:
- Other
- Check frequency:
- Event-triggered
- Products/Services:
- Technical documentation and EU declarations of conformity and certificates of conformity.
- Checking responsibility:
- Manufacturer; where appointed, the authorised representative for delegated duties.
- Check method:
- Document production and retention checks by the market surveillance authority.
- Rule set:
-
-
- Source reference:
- § 5 Absatz 4
- Source excerpt:
- Der Hersteller muss die technischen Unterlagen und die EU-Konformitätserklärung oder die Konformitätsbescheinigung ab dem Inverkehrbringen des Produkts für die Dauer von zehn Jahren für die Marktüberwachungsbehörden bereithalten.
|
|
|
Continuing production conformity |
Governance |
-
|
|
|
- Description:
- The manufacturer must use appropriate procedures to ensure continuing conformity of series production and appropriately take relevant changes into account.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Series-produced products and products affected by changes to design, characteristics, standards, or technical specifications.
- Checking responsibility:
- Manufacturer.
- Check method:
- Appropriate production and change-control procedures.
- Rule set:
-
-
- Source reference:
- § 5 Absatz 5
- Source excerpt:
- Der Hersteller muss durch geeignete Verfahren dafür zu sorgen, dass bei Serienfertigung stets Konformität mit den Anforderungen dieser Verordnung sichergestellt ist.
|
|
|
Product monitoring and complaint management |
Record Keeping |
-
|
|
|
- Description:
- Where appropriate in view of product risks, the manufacturer must take and test samples, investigate complaints, and, where necessary, maintain a register.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Products placed on the market by the manufacturer that carry associated risks.
- Checking responsibility:
- Manufacturer; distributors must be kept informed of monitoring activities.
- Check method:
- Sampling, testing, complaint investigations, and, where necessary, a register of complaints, non-compliant products, and recalls.
- Rule set:
-
-
- Source reference:
- § 5 Absatz 6
- Source excerpt:
- Wenn es der Hersteller angesichts der Risiken, die mit einem von ihm auf dem Markt bereitgestellten Produkt verbunden sind, als angemessen betrachtet, nimmt er zum Schutz der Gesundheit und Sicherheit der Endnutzer Stichproben, prüft diese und untersucht Beschwerden.
|
|
|
Corrective measures and risk notification |
Due Diligence |
-
|
|
|
- Description:
- Where there are reasonable grounds, the manufacturer must immediately restore conformity or withdraw or recall the product and, where risks exist, inform the relevant market surveillance authorities.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Non-compliant or risky products of the manufacturer.
- Checking responsibility:
- Manufacturer; market surveillance authorities monitor and assess the measures.
- Check method:
- Assessment of non-compliance and implementation of corrective, withdrawal, or recall measures; notification to market surveillance authorities.
- Rule set:
-
-
- Source reference:
- § 5 Absatz 7
- Source excerpt:
- Hat der Hersteller Grund zu der Annahme, dass ein von ihm in den Verkehr gebrachtes Produkt nicht den Anforderungen dieser Verordnung entspricht, ergreift er unverzüglich die erforderlichen Korrekturmaßnahmen, um die Konformität herzustellen, oder er nimmt das Produkt zurück oder ruft es zurück.
|
|
|
Importer verification duties |
Due Diligence |
-
|
|
|
- Description:
- The importer may place products on the market only if they comply and it has verified, in particular, the conformity assessment, technical documentation, required markings, declarations, and German-language instructions and safety information.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products from third countries placed on the market by importers.
- Checking responsibility:
- Importer.
- Check method:
- Pre-market verification of conformity assessment, technical documentation, markings, declarations, and German-language information.
- Rule set:
-
-
- Source reference:
- § 8 Absatz 2 Nummer 1
- Source excerpt:
- Der Einführer darf ein Produkt erst in den Verkehr bringen, wenn er sichergestellt hat, dass der Hersteller das Konformitätsbewertungsverfahren nach § 13 Absatz 1 Satz 1 durchgeführt hat.
|
|
|
Storage and transport conditions |
Due Diligence |
-
|
|
|
- Description:
- Importers and distributors must ensure that storage and transport conditions do not adversely affect product conformity.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Products under the responsibility of an importer or distributor.
- Checking responsibility:
- Importer or distributor.
- Check method:
- Monitoring of storage and transport conditions.
- Rule set:
-
-
- Source reference:
- § 8 Absatz 4
- Source excerpt:
- Solange sich ein Produkt im Verantwortungsbereich des Einführers befindet, ist dieser dafür verantwortlich, dass die Lagerungs- und Transportbedingungen die Übereinstimmung des Produkts mit den wesentlichen Gesundheits- und Sicherheitsanforderungen nach Anhang II der Richtlinie 2014/34/EU in der Fassung vom 9. Oktober 2024 nicht beeinträchtigen.
|
|
|
Distributor checks before making available |
Due Diligence |
-
|
|
|
- Description:
- Before making products available on the market, the distributor must verify the required markings, conformity documents, German-language operating instructions and safety information, and manufacturer and importer details.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products made available on the market by distributors.
- Checking responsibility:
- Distributor; the market surveillance authority may request evidence.
- Check method:
- Verification of CE marking, declaration or certificate of conformity, German-language documentation, and manufacturer and importer information.
- Rule set:
-
-
- Source reference:
- § 10 Absatz 2 Nummer 1
- Source excerpt:
- Bevor der Händler ein Produkt auf dem Markt bereitstellt, hat er zu überprüfen, ob das Produkt, sofern es sich um ein Gerät, ein Schutzsystem oder eine Sicherheits-, Kontroll- oder Regelvorrichtung handelt, mit der CE-Kennzeichnung versehen ist und ihm die EU-Konformitätserklärung beigefügt ist.
|
|
|
Traceability of economic operators |
Record Keeping |
-
|
|
|
- Description:
- Upon request, the economic operator must identify the operators from whom it received a product and to whom it supplied it, and must be able to provide this information for ten years.
- Frequency:
- Other
- Check frequency:
- Other
- Products/Services:
- Products received or supplied by economic operators.
- Checking responsibility:
- Economic operator.
- Check method:
- Production of identity and supply-chain information upon request by the market surveillance authority.
- Rule set:
-
-
- Source reference:
- § 12 Absatz 1
- Source excerpt:
- Der Wirtschaftsakteur nennt den Marktüberwachungsbehörden auf deren Verlangen die Wirtschaftsakteure, von denen er ein Produkt bezogen hat und an die er ein Produkt abgegeben hat.
|
|
|
Duties under emergency authorisations |
Approval |
-
|
|
|
- Description:
- The manufacturer must declare that the product fulfils all essential health and safety requirements and is responsible for conformity assessments prescribed by the competent authority. Where an authorisation has been extended across the European Union, the economic operator must affix the required notice before placing the product on the market.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products subject to the emergency procedure under Section 14a and authorised without the regular conformity assessment procedure.
- Checking responsibility:
- Manufacturer or applying economic operator.
- Check method:
- Evidence of essential requirements, completion of conformity assessments prescribed by the authority, and, where applicable, affixing a crisis-relevant-goods notice.
- Rule set:
-
-
- Source reference:
- § 14c Absatz 8
- Source excerpt:
- Der Hersteller eines Produkts, das dem in Absatz 1 genannten Genehmigungsverfahren unterliegt, hat zu erklären, dass das betreffende Produkt alle wesentlichen Gesundheits- und Sicherheitsanforderungen gemäß Anhang II der Richtlinie 2014/34/EU in der Fassung vom 9. Oktober 2024 erfüllt.
|
Emtract Ingest