Fede­ral Cabi­net adopts Medi­cal Devices EU Adjus­t­ment Act

Chan­ges to Euro­pean rules for the manu­fac­tu­re and mar­ke­ting of medi­cal devices within the EU, in the form of the MDR and IVDR , have resul­ted in amend­ments to Germany’s natio­nal medi­cal devices law.

The Medi­cal Devices EU Adjus­t­ment Act (PDF) adapts Germany’s natio­nal Medi­cal Devices Act so as to con­form to the modi­fied EU guidelines.

The cen­ter­pie­ce of the sta­tu­te is the Medi­cal Devices Imple­men­ting Act, which replaces the “old” Medi­cal Devices Act. One chan­ge from the pre­vious rules of the Medi­cal Devices Act is that the two super­vi­so­ry aut­ho­ri­ties respon­si­ble for pro­duct sur­veil­lan­ce at the fede­ral level, the Fede­ral Insti­tu­te for Drugs and Medi­cal Devices (BfArM) and the Paul Ehr­lich Insti­tu­te (PEI), will have expan­ded powers. In the future, they will be aut­ho­ri­zed to take pro­tec­ti­ve mea­su­res which they deem neces­sa­ry to pre­vent unju­s­ti­fia­ble risks to pati­ent and/or user safe­ty ari­sing from medi­cal devices based on risk assess­ments which are to be con­duc­ted on their own respon­si­bi­li­ty. The­se mea­su­res include pro­hi­bi­ting (fur­ther) dis­tri­bu­ti­on and mar­ke­ting of pro­ducts in the natio­nal mar­ket, as well as recalls. Pre­vious­ly, only the natio­nal super­vi­so­ry aut­ho­ri­ties had this authority.

In addi­ti­on, the Coun­cil of Europe’s “Medicrime” Con­ven­ti­on is (final­ly) to be imple­men­ted with respect to medi­cal devices. The goal of the Con­ven­ti­on is to com­bat the coun­ter­feit­ing of medi­cinal pro­ducts and medi­cal devices as effec­tively as pos­si­ble by streng­thening coope­ra­ti­on among eco­no­mic ope­ra­tors in the indus­try. The Con­ven­ti­on will first have to be imple­men­ted into natio­nal law. 


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