Medical Device and PPE Compliance

Conformity Assessment and Testing of Medical Devices (MD) and Personal Protective Equipment (PPE)

Class I Medical Device Conformity Assessment

FACT

Article 11 of Directive 93/42/EEC and Article 52 of Regulation (EU) 2017/745 (…) establish the specific conformity assessment (CA) procedures applicable to the different MD classes.

Pursuant to these articles, class I MDs, with the exception of custom-made or experimental devices, must be subject to the CA procedure for the purposes of the EC declaration of conformity. This procedure does not require the intervention of a third-party conformity assessment body.

Relevant information:
INFARMED Conformity Assessment

SOLUTION

ISQ services to support the manufacturer in carrying out the CA procedure and in the respective assessment itself, to be submitted to the inspection authority (INFARMED), with regard to verification that the MDs ensure an adequate level of health and safety, in accordance with the essential requirements set out in Regulation (EU) 2017/745, and the requirements of Directive 93/42/EEC, for the purpose of making these products available on the market to healthcare professionals.

HOW WE DO

• ISQ is available to support the CA, through the preparation and evaluation of technical documentation on site. This on-site assessment is considered sufficient for Class I DM.
• If the aforementioned documentation does not exist, ISQ advises the manufacturer in its preparation, representing it in this matter.

Conformity assessment of Personal Protective Equipment

FACT

Considering that certain types of PPE used in the context of the COVID-19 outbreak may also be used for other purposes, it is necessary for Member States to take all appropriate measures to ensure that PPE without CE marking, which can be placed on the Union market in accordance with paragraph 8 of Commission recommendation (EU) 2020/403, be made available only to healthcare professionals.

PPE that does not bear the CE marking may also be evaluated and form part of a purchase organized by the competent authorities of the Member States, provided that it is ensured that such products are only available to healthcare professionals during the current health crisis, and that do not enter the normal distribution channels and are not made available to other users.

SOLUTION

ISQ services to support the manufacturer, as a third-party CA body, in the assessment and contact with the surveillance authorities (ASAE), for the purpose of placing PPE on the Union market for a limited period or while the CA procedure is being carried out , in accordance with the essential requirements set out in Regulation (EU) 2016/425.

HOW WE DO

• Support for the aforementioned CA, as a third-party organization of the CA.
• Completion of the security and performance requirements assessment report.
• Verification of the issuance of the declaration of commitment of conformity of the products.
• Monitoring of PPE distribution and sales channels among health professionals.

Tests on view

FACT

This type of PPE has been widely used by security forces and also by health professionals as a complementary PPE to masks.

In the current context of a pandemic, the DGS informs that, regarding the visors, these can be made available, the manufacturer must notify the ASAE of documentary evidence that shows the following information: technical data sheet containing the technical specifications, namely size, properties, associated risk, the composition, packaging and storage, which proves that the product is safe, and photographs of the product (in which the place of affixing the lot, identification of the product and the manufacturer is visible). After the date of notification to ASAE, the manufacturer will have a maximum period of 6 months to decide whether to place these products on the market in accordance with Union harmonization legislation.

However, for the placing on the market of these products and CE marking, it is necessary to comply with the legislation harmonized by the Union.

SOLUTION

ISQ performs the necessary tests and supports the manufacturer in the Conformity Assessment.

HOW WE DO

• Carrying out tests according to EN 167:2001.
• Carrying out tests according to EN 168:2001.
• Support to the manufacturer in the PPE Conformity Assessment.