According to the German Bundestag, after the corona-related postponement of the date of application of EU Regulation 2017/745 on medical products, the federal government has submitted a draft bill to amend the so-called Medical Products Law Implementation Act (MPDG) (19/26942). Evidently this would make adjustments to the MPDG and other legislation necessary as a result of the postponement.
The effective date of Regulation 2017/745 has been deferred by one year from 26 May 2020 to 26 May 2021. The need for change at short notice was addressed in the year 2020 in the Second Civil Protection Act. The current draft provides for various amendments to the MPDG.
The Act serves to make adjustments to EU Regulations. The reform is aimed at a smoothly functioning internal market for medical products as well as high standards for quality and safety of medical products. EU Regulation 2017/745 on medical products is scheduled to take effect in May 2021, and EU Regulation 2017/746 on in-vitro diagnostic medical devices in May 2022.
Amongst other things, the amendments now planned concern transitional provisions, reporting obligations of the inspector or principal inspector to the sponsor of a clinical trial, procedural rules for the risk assessment of medical products owned by patients and a regulation of the competent market surveillance authority for products offered via the Internet.
In the current draft of the new version of the MPDG, Art. 6 of (EU) Regulation 2017/745 on distance selling of medical products is likewise taken into account. This serves to close a gap in market surveillance of medical products offered online. This means that online platforms can be blocked by supervisory authorities if this is necessary in order to protect public health.
Recommendation: Platform operators should make sure that the medical products offered via their online channels, such as the surgical masks that are currently in high demand, actually comply with the statutory requirements and are correctly advertised on the platform.
trade-e-bility supports platform operators in offering only compliant products and in correctly displaying and labelling these products on the platform.
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Please do not hesitate to call trade-e-bility on +49/40/75068730-0 or send an e-mail message to beratung@trade-e-bility.de.
