YOUR SELEON SPECIALIST

Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

Tel.: 07131 2774-40
regulatoryaffairs(at)seleon.de

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30.03.2020

Helping and doing the right thing – We show how protective products become regulatory sound

Protective masks and clothing against corona viruses are in short supply. We are happy to support you on the way to a safe and effective product and speak the language of test laboratories, notified bodies and market surveillance authorities!

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Infection protection products for doctors, hospital and nursing staff, pharmacists, retail staff and ultimately for all of us are in short supply.

In an initial blog entry, we presented the general requirements for masks as medical devices as well as for personal protective equipment (PPE). Now we want to go into more detail. We present all the aspects that must be observed to ensure that safe, effective and regulatory-sound products are created in the shortest possible time. We also show the currently discernible routes via test laboratories and approval authorities.

On 13.03.2020 the European Commission issued the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.

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 urgency of the situation, and to make them available on the market quickly.

What does this mean in practice for PPE and medical device manufacturing-"freshmen" in times like these?

  • Manufactured products must achieve an adequate level of health and safety in accordance with the Essential Requirements contained in the Regulation on Personal Protective Equipment (EU) 2016/425 (PPE) or the Medical Devices Directive 93/42/EEC (MDD). (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 the moment)
  • It must be ensured that necessary conformity assessment procedures are basically carried out or subsequently successfully completed - as quickly as 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 harmonised standards. This type of design interpretation influences all areas of the product and includes

  • Intended Use: Determines whether the product is a medical device, PPE or possibly neither of the two - depending on the use, indication, target / user group, conditions
  • Design, mode of operation: Products should be based on technical solutions such as harmonized standards, the current state of the art or other recognized sources (e.g. WHO recommendations). In the case of protective masks these are, for example, EN 14683 and EN 149 and in the case of 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 ?duration with user and patient are just as relevant as the application environment. The usability of medical devices is an essential factor in order to use the product effectively and safely. The relevant standards in this case are EN 62366-1 in conjunction with EN ISO 14971.
  • Production conditions and product preservation: PPE and medical devices should be safe and provide protection. It is therefore essential to pay attention to possible contamination before, during and after production. Remaining production aids and so-called bioburden (germ contamination on the product) can even make the final product a safety risk for users and patients (insufficient sterilization or protective equipment contaminated with viruses/bacteria). Basic requirements are defined in 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 (explained 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 it is used, without compromising its 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 meet increased requirements which are defined in EN ISO 11607-x.

The adequate implementation of all these requirements must be proven by appropriate product tests or similar. At this we can help you owing to our good relations with established test laboratories and organize the tests for you quickly and easily.

Masks can be made on the basis of existing textile raw materials and patterns. However, these will only provide superficial protection and are probably not fully effective in relation to the existing requirements for such medical devices. On the way to a safe and effective product, many mistakes can be made, which, in addition to financial risks, can also cost human lives.

The German Medical Devices Act, for example (see MPG Art. 40 - 43) threatens with heavy 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 can be that required materials (not low in harmful substances, lack of technical properties) were not used, production conditions (too high germ load, lack of sterilization) were not adequate, or the technical solution is not sufficient for corresponding medical devices.

Furthermore, it is also a criminal offence to declare a performance or security for a product or to market it accordingly, which neither is proven nor can be expected. In the context of the threat posed by the corona virus, medical devices illegally placed on the market could endanger a large number of people, putting up with the risks of death or serious damage to body and health, or a pecuniary advantage being obtained out of gross self-interest. In addition, it is a criminal offence if manufacturers fail to fulfil their notification obligations, evade market surveillance (MPG, Art. 25 - 31) or place medical devices with CE marking on the market without having received temporary approval by a competent authority - in the current case "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 the regulatory tasks. Here a temporary possibility of placing medical devices on the market in the context of the corona threat is possible. An informal application must be submitted to the BfArM for this purpose, but it is recommended to negotiate with the BfArM fee-based beforehand.

The basis for the temporary approval (taking into account common requirements of the RKI and the WHO), which is limited to the application in the context of the corona threat, is compliance with the relevant essential requirements with emphasis on the fulfilment of applicable technical standards.

Masks which are already legally marketed in the USA, Japan, Canada or Australia and which meet the applicable normative requirements can also be placed on the market for a limited period of time via an application to the BfArM.

For personal protective equipment (PPE), DEKRA, in consultation with the ZLS and the Institute for Occupational Safety and Health of the DGUV (IFA), has summarised in a policy paper how PPE protective masks can be tested for effectiveness in a rapid procedure. As Mr. Dirk Wessels of 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 costs for DEKRA amount up to 5,000 to 10,000 Euros depending on the product. The test results are passed on to the ZLS and the market surveillance authority of the respective manufacturer. In contrast to the other approval process, no type test certificates are being issued, the manufacturer is accordingly not allowed to affix a CE mark, and the product is tolerated on the market for a limited period exclusively for protection against the corona virus.

Over the past decades, seleon GmbH has gained extensive experience with the various relevant product groups and speaks the language of testing laboratories, notified bodies and market surveillance authorities!

We are therefore able to accompany you in the best possible and most efficient way on your way to a compliant product.

We can support you with

  • designing,
  • product testing,
  • creating the necessary technical documentation and
  • gaining approval, but also
  • producing due to lack of capacity

We are ready for service 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 not guaranteed and are for information purposes only.

Due to the rapidly changing situation in the context of the Covid 19 pandemic, changes in legal or regulatory requirements may arise at short notice, which we cannot reflect on a daily basis.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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