We, the Consulting division of seleon GmbH, have received an enormous number of inquiries on the topics of importing, placing on the market and manufacturing of face masks in the last few weeks. Now we have collected and compiled for you here the latest information and our experiences after this intensive and busy month, many contacts with authorities, importers and manufacturers of masks.
Our highlights:
The ZLS has now named 4 bodies that can carry out the fast-track procedure for placing on the market without a CE mark on personal protective equipment (PPE).
The BfArM keeps the information on Corona masks up to date on their site, so it makes sense to take a look every now and then.
Currently, no BfArM fees are charged for special approvals.
The BfArM does not give any information about the processing time of the special approval – the better prepared, the faster it will be. Currently, the receipt of an acknowledgement of receipt alone takes 2 – 3 days. It therefore seems sensible to submit the application as soon as it is clear that the project is to be tackled, but not all the documents are available yet, for example.
Products that are placed on the market without CE marking due to the special approval may only be used in medical and system-relevant facilities.
To address the current crisis situation regarding Covid-19 containment, MNS and FFP masks that are marketable in the United States of America, Canada, Australia or Japan (not in China!) may also be considered marketable in Germany, 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.
Personal protective equipment (PPE) can also be handled by the BfArM as part of the special approval process, since FFP masks without an exhalation valve also have a medical purpose for the special anti-corona use case.
The BfArM also shows a precise definition of community masks. In addition, it is pointed out that when describing/advertising an oral-nasal mask by the manufacturer or supplier, care must be taken not to create the impression that it is a medical device or protective equipment. Particular clarity is required in the name and description of the mask, which should not imply a protective function that has not been proven. Rather, it should be explicitly stated that it is neither a medical device nor personal protective equipment.
The masks should only be used for private use.
The German government has launched the draft bill 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 check the information on relevant websites on a daily basis to keep you up to date.
Most of the inquiries we receive are on the topics of importing and manufacturing masks.
FAQ – the most common questions that reach us. And our answers:
What has to be considered when importing?
In the case of products with CE marking, the documentation must be checked carefully, as more and more counterfeit products and certificates are in circulation. Importers also have a responsibility here, which they must fulfill accordingly.
What has to be considered for the special approval via the BfArM?
The importer and applicant becomes the legal manufacturer and thus assumes all responsibility for the product. I.e. if falsified documents are submitted, there may be legal consequences, or at least rejection of the special approval. Here, too, it is important to note that documents must be checked professionally.
We will gladly support you in checking your documents and we will gladly take over the communication with the authority for the special approval for you.
What else do importers and manufacturers have to consider before introducing the products?
Economic operators for medical devices (manufacturers, authorized representatives (EC-REP), importers) must register electronically with DIMDI. DIMDI forwards the notification to the responsible 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 legally placed on the market.
Can seleon GmbH continue to support us?
We continue to offer long-term support to manufacturers of medical devices and personal protective equipment in carrying out the regular conformity assessment procedure to obtain the CE mark, so that the products can continue to be placed on the market in the long term and after the special approval has expired.
We can assist you with
Design layout,
product testing,
preparation of the necessary technical documentation and
approval but also
production due to lack of capacities
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.
