The first corrigenda to MDR and IVDR have been discussed and released by the European Union. Some of the corrections changed the MDR and IVDR formally, whilst some others intervened on the content of the Regulations. No major changes occurred with regards to timelines for Medical Devices and In Vitro Diagnostics applying to Manufacturers. The draft corrigenda were published by the European Council on March 13th and some time was left to Member States to present their observations until March 20th. The final versions of the corrigenda were published on May 3rd.
Other than some formal corrections and adjustments, the main changes to MDR may be summed up as follows: art. 10(15) was amended as to specify that in case the manufacturers have their devices designed or manufactured by another legal or natural person, details on the identity of that person shall be part of the information to be submitted to EUDAMED in accordance with Article 29(4). Such information includes, among others, Basic UDI-DI, type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body and the link to the information that appears on the certificate and was entered by the notified body in the electronic system on notified bodies and certificates, Member State in which the device is to or has been placed on the market in the Union, risk class of the device, where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation registration in the electronic system on clinical investigations. A similar corrigendum was put forward with regards to IVDR. In fact, in case IVD manufacturers outsource the design or the actual production of their devices, information on the identity of the legal or natural person that is responsible for the design or actual manufacturing process has to be submitted to EUDAMED according to art. 26(3) of the IVDR.
A slight modification occurred with regards to art. 120(10). The article originally provided for devices falling listed in points (f) and (g)of Article 1(6) which had been legally placed on the market prior to 26 May 2020 to still be legitimately placed on the market and put into service in the Member States concerned. One of the recently released corrigenda removed point f from art. 1(6), excluding from the scope of the article devices manufactured utilizing tissues or cells of animal origin, or their derivatives, which are non-viable or are rendered non-viable.
The scope of fourth indent in Section 4.5.2 in Annex VII, point (a) was slightly widened as to cover the entire range of devices covered by the certificate. A similar modification was brought about with regards to the IVDR. In particular, the sampling plan (referred to in Annex VII to the Regulation) that has to be drawn up by the Notified Bodies for auditing purposes in order to assess technical documentation should ensure that the entire range of devices covered by the certificate is sampled throughout the certificate’s period of validity.
The issue of classification of accessories has been clarified by a corrigendum that slightly modified Annex VIII, Section 3.2. It is now clearly stated that accessories for a device without an intended medical purpose (the ones listed in Annex XVI) shall not be classified in their own right anymore.
More on the IVDR corrigenda, recital 66 of the Regulation was slightly modified as to replace ISO 14155:2011 with ISO:20916 as the standard to which rules on performance studies should conform to.
A minor change was finally put forward with reference to the date starting from which the coordinated assessment procedure for performance studies referred to by art. 74 should be applied. The 25th of May was substituted to the 27th of May 2029. In fact, starting from this date, all Member States will be required to apply such procedure.
Francesca Zuccarello Cimino
Regulatory Department
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