Simplified market access for medical devices and medical protective equipment
On 13 March 2020, the EU Commission issued a recommendation on conformity assessment and market surveillance procedures in the context of the COVID-19 threat, which is also being implemented in Germany. The aim is to simplify the market access for respirators and medical face masks.
The German Federal Ministry for Pharmaceuticals and Medical Products (BfArM) can now issue temporary permits for protective masks if they guarantee an appropriate level of health and safety but have not gone through a proper conformity assessment procedure.
Even PPE or medical products without CE marking can be included in an officially organised procurement process, provided that it is ensured that these products are only available to medical professionals and only for the duration of the current pandemic and that they do not find their way into the normal sales channels and be made available to other users. This results from § 11 MPG in conjunction with Paragraphs 7, 14 COMMISSION RECOMMENDATION (EU) 2020/403.
At times, protective masks without a CE mark may also be used in hospitals, provided that the BfArM has determined their effectiveness in a simplified procedure.
Please note that this regulation is only limited in accordance with § 11 MPG. After the massive health threat from SarsCoV2 has ended or when the supply situation has eased again, the simplified market access will be ended again. Then only medical products and personal protective equipment may be brought onto the market in Europe if they are certified according to the usual conformity assessment procedure.