The EU publishes guidance papers on medical devices, including respirators, in the fight against Corona. Also: BfArM ends special approvals for masks.
The EU provides a wide range of information on medical devices relevant in the fight against Corona on its new website at https://ec.europa.eu/health/md_sector/overview.
Publication of guidance papers around medical devices related to COVID-19:
For example, the new EU website now features a number of guidance papers of interest to all medical device (MP) and in vitro MP (IVD) stakeholders regarding their roles and responsibilities under the new MP and IVD regulation. For example, the Q&A guide has been updated to describe conformity assessment procedures for PPE and MP under COVID-19.
The guide is aimed at manufacturers and, among other things, outlines the EU regulatory framework and mandatory EU standards that must be met during production. Additional questions continue to be added to the document and can be found HERE.
EC guidance on regulatory requirements for medical face masks published
In response to a recent event, the EU Commission has published guidance on the regulatory requirements for medical face masks under Directive 93/42/EEC and Regulation (EU) 2017/745. The guide can be found here: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_guidance-reg-req-med-face-masks.pdf
CEN publishes free workshop agreement on face coverings (community masks).
The document CWA 17553:2020 “Community face coverings – Guide to minimum requirements, methods of testing and use” presents minimum design, manufacturing and performance evaluation requirements for community masks and is available for free download. The agreement can be found here.
Guidance on legal requirements for devices related to COVID-19
The Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context explains legal requirements for marketing, what standards can currently be used, and where deviations from normal conformity assessment procedures are possible. This information can be found HERE.
In addition to the guidance papers, the updated EU website now includes new information on the impact of COVID-19 and an extensive list of medical devices deemed essential in the context of COVID-19. This List of COVID-19 essential MDs and IVDs could serve as a guide to Notified Bodies for possible priority treatment in conformity assessment procedures and is therefore of particular interest.
Medical devices now listed as essential there include:
Medical face masks
Surgical or examination gloves
Area garments such as gowns and coats for non-surgical use, covers for boots, caps
Various ventilators and their accessories (invasive and non-invasive, for transport and emergencies, anesthesia ventilators)
COVID-19 test kit (PCR, antigen, antibody, including rapid tests)
Sampling Kits
MP qualified software/apps
And others more
The full list can be found here:
https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_list-covid19-essential-md.pdf
EU Commission (JRC) makes available IVD performance database COVID-19
In order to collect all publicly available information on the performance of CE-marked IVDs as well as laboratory-developed devices and test methods for COVID-19 in one place, a COVID-19 database for IVDs and test methods has been made available by the Joint Research Centre, the EU Commission’s in-house scientific service.
This up-to-date and centralized information is intended primarily to support EU states in their decisions on national testing strategies, but also to assist manufacturers in the further development of their products. Manufacturers are invited to submit performance data on new products that can contribute to an update of the database after testing.
More information can be found here.
In addition to many types of masks, face shields also seem to be gaining in popularity. Face shields fall under the PPE regulation. They are used, for example, during operations, examinations or in dentistry to prevent the entry of infectious agents via the mucous membranes of the mouth and nose or via the conjunctiva of the eyes. Depending on their length, they can protect the face or neck from external agents such as splashes.
Face visors do not protect against potentially pathogenic aerosols, but can be a supplement to respiratory protection.
As Category II personal protective equipment (PPE) under Regulation (EU) 2016/425, face shields may only be made available on the market if they comply with the provisions of the PPE Regulation. As part of the conformity assessment procedure, a type examination is also carried out here by a notified body. In the case of PPE, the risks and the extent to which the user is protected must be clearly marked. More information on PPE and the face visors can be found on the website of the Federal Institute for Occupational Safety and Health (BAuA): https://www.baua.de/DE/Themen/Arbeitsgestaltung-im-Betrieb/Coronavirus/FAQ/PSA-FAQ_node.html.
BfArM and ZLS: End of special approvals for masks decided
BfArM: Based on the current state of knowledge, the BfArM has determined that there is now no longer a supply shortage for medical face masks as well as particle-filtering half masks (FFP2 and FFP3) for the medical purpose of infection protection in the SARS-CoV-2 pandemic situation. Thus, special approval is no longer necessary or justified in the interest of public health or patient safety. The updated assessment of the situation will be used by BfArM as a basis for application evaluations of applications for special marketing authorizations received since July 1, 2020, in accordance with Section 7 (1) of the German Medical Devices Implementation Act (MPDG) and Article 59 (1) of Regulation (EU) 2017/745. Any special approvals for corresponding medical devices on the basis of applications already available or received by June 30, 2020, were generally limited in time to August 31, 2020, at the latest. Further information on the subject of special approvals can be found on the BfArM website: https://www.bfarm.de/SharedDocs/Risikoinformationen/Medizinprodukte/DE/schutzmasken_sonderzulassung.html.
ZLS: The ZLS also considers the supply bottleneck for particle-filtering half masks to be over and published a decision on August 11, 2020, which ends the exemptions granted in connection with first-time provision on the EU internal market. Based on a letter from the BMAS dated July 31, 2020, the central requirement of a shortage situation for the exemption possibilities according to Section 9 (1) and (2) MedBVSV can no longer be assumed. A transitional period applies, the cut-off date is October 1, 2020. Since the market surveillance authorities will not issue confirmations of marketability at the end of September 30, commissioning of tests will only make sense if test procedures and issuance of the assessment letter can be completed before September 30, 2020. Tests commissioned before August 14, 2020 are not affected by this.
http://www.zls-muenchen.de/Corona/index.htm
http://www.zls-muenchen.de/Corona/Atemschutzmasken/201001_AAMue_FFP%20Masken.pdf
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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.
