PPE AND MEDICAL DEVICES

CONFORMITY ASSESSMENT OF CLASS I MEDICAL DEVICES

FACT

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

Pursuant to these articles, with the exception of custom-made or experimental devices, Class I MD shall 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 Compliance Assessment

SOLUTION

ISQ services to support the manufacturer in implementing the CA procedure and in carrying out the assessment per se to be submitted to the supervisory authority (INFARMED), verifying that MD ensure a suitable level of health and safety in accordance with the essential requirements laid down in Regulation (EU) 2017/745 and the requirements of Directive 93/42/EEC for the purpose of making such products available on the market to health professionals.

HOW WE DO IT

ISQ is available to support the CA by developing and evaluating on-site technical documentation. This on-site assessment is considered sufficient for Class I MD.

If the documentation referred to above does not exist, ISQ shall advise the manufacturer to prepare it and act as representative.

COMPLIANCE ASSESSMENT OF PERSONAL PROTECTIVE EQUIPMENT

FACT

Considering that certain types of personal protective equipment used in the context of the COVID-19 outbreak can also be used for other purposes, Member States must take appropriate measures to ensure that equipment not carrying the CE mark and may be placed on the European Union market in accordance with paragraph 8 of Commission Recommendation (EU) 2020/403 is made available only to healthcare professionals.

PPE not bearing the CE marking may also be assessed and be part of a purchase organised by the competent authorities of the Member States, provided that it is ensured that such products are only available to health professionals during the current health crisis and do not enter the normal distribution channels or are 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 supervisory authorities (ASAE) for the purpose of placing PPE on the EU market for a limited period or while the CA procedure is being carried out; in accordance with the essential requirements laid down in Regulation (EU) 2016/425.

HOW WE DO IT

• Support for the said CA as CA third party.
• Implementation of the safety and performance requirements assessment report.
• Verify that the declaration of conformity of the products is issued.
• Monitoring the distribution and sale channels of PPE to health professionals.

ASSAYS TO SURGICAL MASKS (MEDICAL DEVICE), SEMI-PROTECTIVE MASKS (PPE)

FACT

For the purposes of preventing contagion with the new Coronavirus, it has been recommended that health professionals wear masks that are regulated as MD (type II and IIR surgical masks) and as PPE (FFP2 and FFP3 filtering half masks for respiratory protection).

Standard EN 14683:2019, harmonised within the scope of the Medical Devices Directive, is intended for masks for clinical use, classifying them into different types (I, II and IIR) according to their characteristics, namely: bacterial filtration efficiency, pressure differential (air permeability), resistance to splashes, and microbial cleansing.

Masks intended to be worn by users with a view to protecting them against one or more risks likely to pose a threat to health or safety shall be classified as PPE. Standard EN 149:2001+A1:2009, applicable to filter respiratory protection devices, in particular to so-called “respirators” or “self-filter half masks”, classifies such equipment as FFP1, FFP2 and FFP3, taking into account filtration efficiency and maximum leakage to the inside.

SOLUTION

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

HOW WE DO IT

• Conducting tests according to EN 14683:2019.
• Conducting tests according to EN 149:2001+A1:2009.
• Supporting the manufacturer in the Conformity Assessment of Class I DM or PPE.

VISOR TESTS

FACT

This type of PPE has been widely used by security forces and also by health professionals to complement face masks.

In the current context of the pandemic, DGS (the Portuguese health authority) has stated that visors may be made available; the manufacturer shall notify ASAE of documentary evidence containing the following information: technical data sheet containing the technical specifications, in particular, size, properties, associated risk, composition, packaging and storage, proving that the product is safe, and photographs of the product (showing the lot number, product name and manufacturer’s name). The manufacturer shall have a maximum of 6 months after notifying ASAE to decide whether to place these products on the market in accordance with Union harmonisation legislation.

However, the law harmonised by the Union must be taken into account in order to place such products on the market and obtain the CE mark.

SOLUTION

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

HOW WE DO IT

• Conducting tests according to EN 167:2001.
• Conducting tests according to EN 168:2001.
• Supporting the manufacturer in the PPE Conformity Assessment.