Products for protection against infections for physicians, clinical and nursing staff, pharmacists, retail employees and ultimately for all of us are in short supply.
In a first article, we introduced you to the general requirements for masks as medical devices and for personal protective equipment (PPE). Now, here’s where we get more specific. We describe all the things that need to be considered to ensure safe, effective and regulatory-clean products in the shortest possible time. We also show the currently recognizable paths via testing laboratories and approval authorities.
The European Commission issued Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures in the context of the COVID-19 threat on 13.03.2020.
The aim is to meet the immense demand for personal protective equipment (PPE) and medical devices, to ensure that they are safe and effective despite the rush, and to make them available on the market quickly.
What does this mean specifically for PPE and medical device manufacturer “newbies” at this time?
Manufactured products must achieve an appropriate level of health and safety in accordance with the Essential Requirements contained in the Personal Protective Equipment (PPE) Regulation (EU) 2016/425 and the Medical Devices Directive 93/42/EEC (MDD), respectively. (Note: The postponement of the European Medical Device Regulation (MDR) 2017/745) by one year has already been announced. Therefore, only MDD 92/42EWG is relevant at this time).
It must be ensured that necessary conformity assessment procedures are carried out as a matter of principle or successfully completed retrospectively – accelerated if possible.
Compliance with the Essential Health and Safety Requirements (PPE Regulation) or the Essential Requirements (MDD) requires a risk-based design interpretation, which should be based on applicable harmonized standards. This type of design interpretation impacts all areas of the product and includes, but is not limited to:
Intended purpose: Determines whether the product is a medical device, PPE, or possibly neither – depending on the use, indication, target/user group, conditions
Design, Mode of Action: Products should be based on technical solutions taken from harmonized standards, the current state of the art or other recognized sources (e.g. WHO recommendations). For example, for protective masks these are EN 14683 and EN 149 and for surgical clothing and drapes EN 13795-1, EN 13795-2.
Material composition: Products must be biocompatible according to their specifications (see EN ISO 10993-1 ff) and free of harmful substances (see CMR list, REACH regulation).
Type of application: Products must always be developed and validated with regard to their intended use. Questions about the end user, the type of contact and the duration of contact with the user and patient are just as relevant here as the application environment. Usability is an essential factor for medical devices in order to be able to use the product effectively and safely. Relevant standards in this case are EN 62366-1 in conjunction with EN ISO 14971.
Production conditions and product maintenance: PPE and medical devices should be safe and provide protection. Therefore, it is essential to pay attention to possible contamination before, during and after production. Residual production aids and so-called bioburden (germ contamination on the product) can even turn the end product into a safety risk for users and patients (insufficient sterilization or protective equipment contaminated with viruses/bacteria). Basic requirements are defined by the EN ISO 11137-x standards.
Necessary information material: For safe and effective use, products require clearly understandable and complete information material. In addition to the usual instructions for use, this also includes brief instructions. The information material must be tailored to the user group and the application complexity of the product (explain as simply as possible) and validated.
Type of packaging: For each product designed and manufactured in conformity, it must be ensured that it can be transported and stored until use without compromising quality and safety. For this purpose, different ASTM (e.g. D4169) and ISTA standards are used to test possible transport and storage conditions. Sterile products have to fulfill increased requirements which are defined in EN ISO 11607-x, among others.
The adequate implementation of all these requirements must be proven with appropriate product tests or similar. Here we can help through our good relationships with established testing laboratories and organize the tests for you quickly and easily.
It is possible to manufacture masks based on existing textile starting materials and patterns. However, these will only provide superficial protection and – in relation to the present requirements for such medical devices – are probably not fully effective. Many mistakes can be made on the way to a safe and effective product, which can cost human lives as well as financial risks.
The German Medical Devices Act, for example (see MPG Art. 40 – 43), threatens high fines and imprisonment of up to 5 years for medical devices placed on the market where it can be proven that the health of patients, users or third parties is directly or indirectly endangered. Reasons for this may be that necessary materials (not low in harmful substances, lack of technical properties) were not used, production conditions (excessive germ contamination, lack of sterilization) were not adequate, or the technical solution is not sufficient for corresponding medical devices.
Furthermore, it is also punishable to declare a performance or safety of a product or to market it accordingly, which is neither proven nor to be expected. In the context of the threat posed by the Corona virus, medical devices that are unlawfully marketed could endanger a large number of people, endanger death or serious bodily harm or health damage, or result in a pecuniary advantage being gained for gross self-interest. In addition, it is a criminal offense for manufacturers to fail to comply with their notification obligations, to evade market surveillance (MPG, Art. 25 – 31), or to place medical devices with CE marking on the market without having received temporary approval from a competent authority in our specific case, which is in the “interest of health protection” (MPG, Art. 11.1).
For medical devices, the Federal Office for Drugs and Medical Devices (BfArM) has published current information on the corona virus in connection with regulatory tasks. Here, a temporary possibility of placing medical devices on the market in connection with the Corona threat is possible. For this purpose, an informal application must be submitted to the BfArM, but it is recommended to consult with the BfArM in advance for a fee.
The basis for the temporary approval limited to use in connection with the Corona threat (taking into account common specifications from the RKI and WHO) is compliance with the relevant Essential Requirements with emphasis on meeting applicable technical standards.
Masks that are already legally marketed in the USA, Japan, Canada or Australia and that meet the applicable normative requirements can also be marketed on a temporary basis via an application to the BfArM.
For personal protective equipment (PPE), DEKRA, in coordination with the ZLS and the Institute for Occupational Safety and Health of the DGUV (IFA), has summarized in a policy paper how PPE protective masks can be tested for effectiveness in a rapid procedure. As Mr. Dirk Wessels from DEKRA Testing & Certification GmbH in Essen informed us, these tests can only be carried out by DEKRA and the Institute for Occupational Safety and Health of the DGUV (IFA). The cost to DEKRA is between 5,000 and 10,000 euros, depending on the product. The test result is passed on to the ZLS and the market surveillance authority of the respective manufacturer. In contrast to the other approval processes, no type examination certificates are issued, the manufacturer is accordingly not allowed to affix a CE mark, and the product is tolerated on the market for a limited period of time exclusively for protection against the Corona virus.
We as seleon GmbH have been able to gather extensive experience with the various relevant product groups over the past decades and speak the language of the testing laboratories, notified bodies and market surveillance authorities!
We are therefore in a position to accompany you in the best possible and most efficient way on your way to a compliant product.
We can assist you with
design layout,
product testing,
preparation of the necessary technical documentation and
approval but also
production due to lack of capacity
support.
We are fully operational and highly motivated and together we defy the COVID-19 threat.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
Due to the rapidly changing situation in the context of the Covid-19 pandemic, there may be changes in legal or regulatory requirements at short notice, which we are unable to reflect on a daily basis.
