Q1: What are the delivery charges?
A1: It’s only £3.75 on all orders! Orders are usually despatched within 24 hours on business days on Royal Mail Tracked 48 service [ https://www.royalmail.com/sending/uk/tracked-48 ]
Q2: What is the difference between Medical Devices (MDD) and Personal Protective Equipment (PPE)?
A2: Besides the composition of each mask sold, they differ essentially in the protection capacity of/for the environment and in the type of recommended users. More broadly, the distinction between the 2 categories is related to the applicable legislation.
Q3: Are there any particular requirements regarding the packaging and labelling of the masks in order to be considered MDD or PPE?
A3: Yes, there are, and refer to mandatory markings, such as identification of the distributor in Europe, the manufacturer, date of production, batch number, expiration date, instructions for use, correct classification, brief description of the mask and general notices. In addition to this, there is also a mandatory CE marking, although we are currently under an exceptional regime in the European Union (Commission Recommendation UE2020 / 403, of 13 March 2020), which will remain in force until at least September this year and which temporarily suspends mandatory marking. In this exceptional regime, the importer is only obliged to present the necessary documentation to the competent authorities of the country where the import is being made, which will have to approve the entry of the product into the European Union and will register the entry on a specific European portal, if the merchandise is in conformity and, from there, the masks can be commercialised in the European space.
Q4: Do these masks need to be sterilised to be recognised as MDD or PPE?
A4: No. None of the masks currently sold are sterile.
Q5: Are these products re-usable? is there any type of standard length (in hours) for each type of mask? Can we wash the masks and use them again?
A5: All masks sold are disposable and cannot be washed or reused. Generally, the maximum time of continuous use is:
- Community masks: 4h
- Surgical masks: 4h
- Masks FFP2/KN95/N95: 6-8h
However, masks must be discarded whenever they become wet, as the filtering capacity decreases.
Q6: What is the difference between a test report, a certificate of conformity, a CE declaration and an EU registration?
A6: The main differences are:-
-Test Report: report that explains the tests performed and the respective results. It must be issued by a specialised laboratory;
- Certificate of Conformity or Declaration of conformity: declaration that attests the conformity of a certain documentation or product with a given applicable legislation. It is issued by a specialised laboratory or CNAS (China National Accreditation Service for Conformity Assessment).
- CE declaration: is a declaration for the European area, issued by the importer or manufacturer and attesting that a product complies with the applicable European legislation. It is mandatory to have a CE declaration in order to be able to put the CE seal on the packaging or on the product itself.
- UE registration: is a registration within the European Union, applicable to PPEs, made by the importer or the manufacturer and which ensures that all current rules are met. Without this registration, it is not possible to place the CE seal on the packaging/product. Currently, with the exception regime in force, this registration is temporarily suspended as to its mandatory nature.
Q7: The tests and certificates are covering the filtering level of the particles, the production standards or the producing entity?
A7: Tests and certificates attest that the product, due to its characteristics, is in compliance with certain legislation and/or standards.
Q8: What is the European legislation that defines the certificates and reports needed to a mask being considered MDD or PPE?
A8: The current European legislation is:
- PPE: EU Regulation 2016/425
- MDD: Directive 93/42 / EEC
- Community Masks: There are only EU recommendations, with 2 conditions: PFE ≥ 70% and Breathability > 8l/min or Differential Pressure <40 Pa/cm2.
Q9: What is the difference between EN 14683: 2019 and EN 14683: 2005?
A9: The 2005 standard was updated to respond to the new regulation, which comes into force in May 2020. However, due to the exception regime currently in force, the 2005 standard remains active. The differences are essentially related to the markings on the packaging/product and a small change in the performance of one of the tests, but which in no way affects or changes the characteristics or the filtering capacity of the masks.