CE mark’s considerations when exporting masks and personal protective equipment to Europe

How can a product be legal with a CE marking when it goes to the EU market?

CE marking

To legally enter the EU market medical devices covered by the Directives or Regulations, as well as personal protective equipment covered by the PPE, these products must have a CE marking with a declaration of conformity (EC) or EU signed and issued by the manufacturer.

In EC or EU declaration of conformity, manufacturers must declare that their products comply with the applicable EU statute (s) and requirements.

However, there is no obligation within the legal framework to make separate statements about compliance with national laws, nor to national, European, or international standards.

European Harmonization Standards

The use of harmonized European standards is voluntary. These standards, developed by relevant European standardization organizations (CEN and CENELEC), contain specific technical solutions that can be used to comply with legal requirements.

When invoking the European harmonization standard cited in the Official Journal of the European Union (OJEU), its use gives the product an assumption of compliance with regulatory requirements. point (as listed in the relevant Annex Z).

In fact, when a manufacturer chooses to comply with a harmonized European standard whose reference is cited in the OJEU, the product is deemed to comply with the applicable legal requirements covered by that standard.

Conversely, when a producer chooses not to comply with a harmonized European standard, he must demonstrate that the alternative engineering solution applied is sufficient to ensure that the product complies with the requirements. current legislation.

The manufacturer must also prepare and maintain relevant technical documentation for the product, to support compliance as stated in the EC or EU declaration of conformity. Such technical documents should be kept and made available to national authorities upon request.

How many types of CE certificates with a CE marking are there?

There are 3 common types of certification:

  • Declaration of conformity / Declaration of compliance is “Declaration of conformity”. This certificate is self-declared by the enterprise, not by a third party
  • Certificate of compliance is “Certificate of compliance”. This Compliance Certificate is issued by a third party, along with test reports and other technical information.
 Declaration of compliance with a CE marking symbol

Declaration of compliance with a CE marking symbol

  • EC Attestation of conformity is “EU certificate of conformity”. This is a certificate issued by the EU Certification Body (Notified Body – NB), and only NB has the right to issue the CE Type of the CE in accordance with the EU regulations.
 EC Attestation of conformity

            EC Attestation of conformity

What is a declaration of conformity?

  • An EC or EU valid declaration of conformity must be drawn up and signed by the manufacturer and include at least:
  • Product identification and description;
  • Statute (s) with a relevant statement of conformity;
  • Name and address of the manufacturer and / or authorized representative, if applicable
  • A statement that the published claim is the sole responsibility of the manufacturer;
  • Applied conformity assessment procedure (s);
  • Reference to the relevant European harmonized standard (s) or the general specification (s) used if any
  • Name and 4-digit identification number (NB xxxx) of the notified institution and reference to the issued certificate (s), if any; CE mark.
  • Date of issue of declaration, identity and signature of manufacturer.

If a product falls within the scope of two or more legislation governing the marking, the manufacturer must draft and sign a declaration of conformity, declaring conformity with two or more parts of Current law.

 This is the case, for example, of “two-purpose” medical protective equipment, such as certain types of masks or gloves, that provide protection for both the user and the patient: they are within the scope of both the MDD and the PPER, therefore the EU Declaration of Compliance will cover both parts of the law.

What are the main features of a valid certificate?

There are two types of certification that can be issued by an authority notified under applicable law, relating to the entry of medical or personal protective equipment on the market: product certificates and certificates only quality management system.

Product certificate

Verification of the product’s compliance with the relevant requirements (after the notified body has reviewed the relevant technical documentation and/or has performed relevant tests).

Quality management system certification.

Certification of the manufacturer’s quality management system for a specified series of products (in whole or in limited aspects of production or product quality assurance).

A certificate that is valid under applicable law (e.g. an EC or EU type test certificate, a design test certificate, or a quality management system certificate) issued by a recognized body. report after successfully completing the conformity assessment process applicable to the product.

Notified bodies are designated by relevant national bodies to carry out the specific conformity assessment procedure (s) and thus issue relevant certification (s), for specific product categories. quality management system or system in accordance with different legislation.

Only notified agencies are listed in the Commission’s NANDO information system.

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501

Role of the notified body

For some medical devices and personal protective equipment (Risk categories II and III, such as respirators), the notified body is involved in the regulatory conformity assessment process (s).

Respiratory protection, in particular, used in the context of COVID-19 (commonly known as an FFP2 or FFP318 respirator) is a category III product, and therefore the notified agency must engage systematically enter conformity assessment procedures before placing these products on the EU market.

Example of the CE marking with the number of the notified body (xxxx)

    Example of the CE marking with the number of the notified body (xxxx)

Once the notified body has assessed the compliance of the product with the relevant requirements of applicable EU law, it will issue the appropriate certification (e.g. an EC type test certificate or EU, design inspection certificate or quality management system. The product must have a CE mark followed by a 4-digit identification number (NB xxxx) of the notified body. Conformity assessment procedures may include evaluating manufacturers and / or critical suppliers/subcontractors, testing or reviewing technical documentation (such as test reports, audits manufacturer’s risk and / or management procedures, drawings and clinical data) to support product compliance with applicable legal requirements.

Any certificate issued by a notified body prior to the introduction of medical or personal protective equipment on the EU market must state the applicable conformity assessment procedure and may include references. to test reports were available and other relevant technical documents, as well as to the European Standards used if this is the case.

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