In order to reduce the impact of COVID-19 and increase the production and supply of protective equipment, the European Commission issued the “Conformity Assessment Procedure for Protective Equipment” guide on March 30, using a question and answer format to explain in detail how manufacturers will The applicable EU legal framework and steps required to put products on the EU market provide compliance guidance for new companies and companies interested in switching to production and sales of protective equipment. The official explanation provided by the guide is of reference significance in solving the recent concerns about quality assurance and compliance certification of protective equipment production and export enterprises in my country. The main contents are as follows:
1. Question: Which EU legal framework applies to protective equipment?
Answer: Non-medical personal protective equipment, such as FFP type masks, etc. are applicable to the “Personal Protective Equipment (PPE) Regulations”, namely EU2016/425 (hereinafter referred to as PPE) . Medical protective equipment, such as medical gloves, surgical masks, intensive care and other medical equipment, etc., fall within the scope of the Medical Device Regulation 93/42/EEC (hereinafter referred to as MDD). This directive will be replaced by the new EU Medical Device Regulation EU2017/745 (hereinafter referred to as MDR) on May 26, 2020. However, on March 25, the European Commission announced a proposal to postpone the implementation of the MDR regulations for one year and submitted it in early April so that it could be adopted by the European Parliament and the Council before the end of May. Both regulatory systems harmonize the performance requirements of the products they cover to ensure the health and safety of users. Products manufactured under these regulations can therefore circulate freely throughout the EU market and EU Member States may not impose additional and different requirements for the manufacture and placing on the market of such products.
2. Question: Are there mandatory EU standards for the production of protective equipment?
Answer: Both PPE and MDD regulations impose basic requirements on the hygiene, safety and performance of the products they cover. However, both EU regulations are technically neutral and do not provide for any specific mandatory technical solutions for product design. Manufacturers can therefore use a variety of technical solutions to meet these basic requirements.
At the same time, both PPE and MDD provide specific technical solutions for manufacturers. These technical solutions are detailed in harmonized standards or parts thereof, the requirements for their adoption being published in the Official Journal of the European Union. If the manufacturer chooses to implement these technical solutions, the product is presumed to comply with the applicable basic hygiene, safety and performance requirements.
For masks, the harmonized standard for FFP masks is EN149:2001+A1:2009, while the harmonized standard for surgical masks is EN14683:2019.
As manufacturers may choose to implement different technical solutions, they are not necessarily bound to adhere to the specific specifications set out in these standards. But the main advantage of using these technical solutions is that following them brings products to market faster. The reason is that if the manufacturer provides evidence that its product has passed all necessary tests specified in the standard, it does not have to have the product tested again by a third party or certification body before placing it on the market.
3. Question: If a manufacturer chooses to follow the EN14683 standard to produce surgical masks, who should perform the tests specified therein?
Answer: The test is specified in the standard and can be performed by the manufacturer or by a laboratory on behalf of the manufacturer. Strictly speaking, these tests are not mandatory steps before placing on the market. However, if the manufacturer claims that the product complies with the standard, then the market supervision agency can test the sample according to the test methods specified in the EN14683 standard based on supervision and management needs.
4. Question: If a manufacturer wants to follow EN149 or EN14683 standards for production, where can these standards be obtained?
Answer: The ownership of European standards belongs to its developer, the European Organization for Standardization. Typically manufacturers must purchase the required standards from national members of the European Organization for Standardization (i.e. national standardization bodies).
However, in order to ensure that European industry can quickly respond to the increased demand for protective equipment caused by the COVID-19 outbreak, the European Commission has reached an agreement with the European Standardization Organization CEN. 14 standards (including EN149 and EN14683) will be provided free and complete to manufacturers by the national standardization agency.
Manufacturers can download the EN149 and EN14683 standards for free from the national standardization body’s online catalog. The complete list and the link to its corresponding website are as follows: https://standards.cen.eu/dyn/www/f?p=CENWEB:5.
5. Question: Can protective equipment comply with other standards?
Answer: Any standard or specific technical solution can be used as long as it meets the basic requirements specified in the EU legal framework applicable to the product. Although harmonized standards (such as those for masks EN149 and EN14683) tend to be the most widely used technical solutions in EU industry, there are other specific technical solutions that ensure the same level of safety. The WHO Guidelines for Selection of Protective Equipment provide guidance in this regard.
But unlike the use of harmonized standards (EN149 and EN14683), if the product is subject to PPE regulations,Within the scope, if the manufacturer chooses to follow the alternative standards provided by the World Health Organization (WHO), product samples should be tested by a notified body (third-party testing agency).
In response to the new coronavirus COVID-19, the European Commission issued the “Conformity Assessment Procedures and Market Supervision and Management under the Threat of the New Coronavirus COVID-19″ on March 13, 2020. Recommendations” (hereinafter referred to as the “Recommendations”) to promote the rapid popularization of new products in the EU market. On the one hand, the European Commission urges all Notified Bodies (third-party testing agencies) to prioritize new applications submitted by manufacturers for products related to COVID-19, emphasizing to the Notified Bodies that the World Health Organization’s guidelines can serve as alternative applicable technologies. solution.
On the other hand, the “Recommendations” provide two situations. Even if the conformity assessment procedure has not been finalized, or in some special cases the conformity assessment procedure has just been started, the product Can be placed on the market:
(1) If the national market surveillance authority considers that the protective equipment placed on the EU market can comply with the basic requirements set out in EU law to ensure a sufficiently high level of hygiene and safety level, regulatory agencies should allow these products to enter the EU market even if the conformity assessment procedures (including the affixation of the CE mark) have not been fully completed.
(2) In special circumstances, if all the following requirements are met, the product can be labeled even if the certification process has not been initiated and the CE mark is not affixed to the product. Placement on the market:
(a) The product is in accordance with one of the EN standards or any other standards mentioned in the World Health Organization WHO guidelines, or is able to ensure a sufficiently high manufactured with technical solutions to the highest level of safety;
(b) the product is part of an organized procurement by the relevant Member State authorities;
(c) Products are only available to health care workers;
(d) Products are only available during the current COVID-19 period;
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(e) The product has not entered regular distribution channels and will not be provided to other users.
In accordance with the requirements of point (a) above, the evaluation of specific technical solutions shall be carried out by the market surveillance authority during the purchase process organized by the relevant authorities of the Member States.
6. Question: What authorizations or compulsory certifications need to be completed before the product is put on the market?
Answer: Surgical/medical masks, examination gloves, and protective gowns (provided in a non-sterile state) are “Class I medical devices.” Therefore they do not require mandatory certification by a notified body (third-party testing agency) before being put on the market. However, the manufacturer must demonstrate that the product complies with its applicable requirements. This system is essentially a self-certification. If such equipment is supplied in a sterile state, it will need to be classified in a higher risk category and will require conformity assessment by a notified body.
On the contrary, masks and other supplies within the scope of PPE regulations used in response to the COVID-19 epidemic are “Class III PPE” products. Certification by a notified body (third-party testing agency) is therefore mandatory in all cases. Before placing a product on the market, samples of it need to be provided to such bodies for evaluation. But according to the PPE regulations, once the initial sample is tested, it is not necessary to perform the same test on every product coming out of the production line. Instead, random inspections of products or other similar production control procedures are performed.
7. Question: Should products bear the CE mark in all cases?
Answer: Pasting the CE mark is the last step before the product is put on the market, marking that all procedures have been completed. For some medical devices, manufacturers can affix this mark without involving a third-party testing agency (e.g., Class I medical devices). For personal protective equipment, the CE mark (for example, Class III personal protective equipment) should usually be affixed by the manufacturer after the first samples of the product have been evaluated and approved by a notified body (third-party testing agency). However, in the specific circumstances of COVID-19 (such as the two situations mentioned in the Recommendations), these requirements may be reduced. It is worth noting that according to PPE and MDD/MDR regulations, every product should bear the CE mark.
8. Question: Are there specifications on the exact materials used to make masks?
Answer: Neither the EU legal framework nor the harmonized standards EN149 and EN14683 impose any mandatory specifications on the materials used. The legal framework essentially introduces performance requirements, which are detailed in relevant standards. It is therefore up to the manufacturer to decide which material to choose.
In actual production, the following materials are mostly used for FFP masks:
(1) Filtration Layer: polypropylene;
(2) Valve (if applicable): rubber or polypropylene;
(3) Straps: polyester fiber, polyisoprene, Lycra;
(4) Sealing: polyethylene foam, polyurethane, etc.;
(5) Clip/U-shaped nail (if applicable): aluminum, steel.
For surgical masks, it is recommended to use a combination of nonwoven materials (type S-M-S) of meltblown and spunbond fabrics. The fabric is usually polypropylene.
��Material (S-M-S type). The fabric is usually polypropylene.
