YOUR SELEON SPECIALIST

Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

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

Questions on this topic?

Send us a message!

 

23.04.2020

Don’t lose the overview in mask fighting

We provide you with the latest information on the import, marketing and manufacture of facemasks.

 

mit-superpower-gegen-den-corona-virus
mit-superpower-gegen-den-corona-virus
mit-superpower-gegen-den-corona-virus
mit-superpower-gegen-den-corona-virus

We, the seleon GmbH consulting unit, have dealt with an enormous number of inquiries regarding the import, marketing and production of facemasks in the recent weeks. We have now compiled the latest information and our experiences following an intense and busy month, many contacts with authorities, importers and manufacturers of masks.

 

Our highlights:

  • Currently, no BfArM fees are charged for special approvals.
  • The BfArM does not provide any information on the processing time for the special approval - the better prepared, the faster it will be. Currently, it takes 2 - 3 days to receive a confirmation of receipt alone. It therefore seems sensible to submit the application as soon as it is clear that the project is being approached, but not all documents are available, for example.
  • Products that are place on the market without CE marking due to the special approval may only be used in medical and system-relevant facilities.
  • In order to cope with the current crisis situation regarding the containment of Covid-19, mouth-nose-protective masks and FFP masks that are marketable in the United States of America, Canada, Australia or Japan (not in China!), and possibly also in Germany, are considered marketable even if they do not carry a CE/NE marking. This means that special approval can be granted here on the basis of the available approval documents.
  • The BfArM may also treat personal protective equipment (PPE) by in accordance with the special approval procedure, since FFP masks without exhalation valve also have a medical purpose for the special anti-corona application.
  • The BfArM also shows an exact definition of community masks. In addition, it is pointed out that when a manufacturer or supplier markets a mouth-nose mask, care must be taken to ensure that it does not give the impression that it is a medical device or protective equipment. Particular clarity is required in the designation and description of the mask, which must not indicate a protective function that has not been proven. Rather, it should be expressly stated that it is neither a medical device nor personal protective equipment.
    The masks should only be used for private use.
  • The Federal Government has launched the draft of the "Ordinance to ensure the supply of the population with products of medical need in the epidemic caused by the coronavirus SARS-CoV-2".

We sift the information on relevant websites on a daily basis to keep you up to date.

Most of the inquiries we receive concern the import and manufacture of masks.

 

FAQ - the most frequent questions that reach us. And our answers:

  • What do I need to consider when importing?
    For products with CE marking, the documentation must be checked carefully, as there is an increasing number of counterfeit products and certificates in circulation. Importers also have a responsibility here, which they must take on accordingly.
  • What has to be taken into account for the special approval via the BfArM?
    The importer and applicant becomes a legal manufacturer and thus assumes all responsibility for the product. This means that if falsified documents are submitted, legal consequences may arise, or at the very least the special approval may be refused. Here too, it is important to note that documents must be checked professionally.
    We will be happy to support you in the examination of your documents and we will gladly take care of the communication with the authority for special approval for you.
  • What else do importers and manufacturers have to consider before introducing the products to the market?
    Economic operators for medical devices (manufacturers, authorised representatives (EC-REP), importers) must register electronically with the DIMDI. DIMDI forwards the notification to the competent state authority for approval. To register, you must first apply for a user code to access the DIMDI website.

Without successful registration, medical devices cannot be placed on the market legally.

  • Can seleon GmbH continue to support us?

Furthermore and in the long term, we offer manufacturers of medical devices and personal protective equipment support in carrying out the regular conformity assessment procedure for obtaining the CE mark, so that the products can also be marketed in the long term and after expiration of the special approval.

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 without guarantee 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 occur 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.

CONTACT YOUR SELEON SPECIALIST

Further entries from the "Regulatory Affairs" category

Regulatory Affairs
08.12.2020

Now that the circle of mask wearers has expanded considerably, it is important to take a close look at the innovations on the market and how different their evaluation can be.

Regulatory Affairs
17.11.2020

In order to obtain a registration number for authorities containing all relevant information on companies/manufacturers and co, economic operators such as medical device manufacturers will have to register in the first of 6 EUDAMED database modules as of 1 December...

Regulatory Affairs
20.10.2020

Although the EU Commission updated the list of harmonized standards for the MDD in March of this year, there is still no list of harmonized standards for the Medical Device Regulation and therefore no harmonized risk management standard.

Clinical Affairs

Clinical affairs of medical devices requires numerous evidences and evaluations. What we know about it …

 

> Clinical Affairs

Quality Management

Medical devices are governed by stringent requirements on quality assurance. We know the details …

 

> Quality Management

Development Excellence

Product development of medical devices is subject to its own rules. We bring light into the darkness …

 

> Development Excellence