Not only does the MDR contain new classification rules (their number has increased from 18 to 22), but considerable modifications have also been made to the existing ones. Manufacturers should therefore begin their regulatory preparations by planning a fresh examination of Annex VIII, initially, in order to determine whether their devices have been reclassified in a new section of Class I, in Class IIa, IIb or even Class III. Depending on the case, the conformity requirements may become much greater and more stringent, forcing manufacturers to enter into contact with a notified body. Manufacturers of reusable surgical instruments, for example, should note that there is now a specific sub-classification for this type of device, Class Ir. In practical terms, this means that the cleaning, repackaging and reprocessing of these devices will now be subject to the control of a notified body.

If no modification has been made to the classification of their Class I products, manufacturers may continue to self-certify, but they must still fulfil the MDR requirements. To do so, they will need to ensure that their technical documentation is up to date, deliver the EU declaration of conformity referred to in Article 19 of the MDR and save the necessary information in the EU medical devices database, EUDAMED. The launch of the EUDAMED database has now been delayed to May 2022,but the data recording requirements still apply. This gives manufacturers the time they need to conduct efficient planning of the implementation requirements and data entry, so that the full data reports are ready in usable file formats when the system does go online.

Once the classification of the devices has been established, it is extremely useful to draw up an implementation schedule. The corrigendum published on 25 November 2019 amends Article 120(3) of the EU MDR. This allows a delay of four years in implementation specifically for those devices that are in the Class I category in the MDD and which will be reclassified in Class Ir (reusable surgical instruments) and/or Im (if they have a measuring function) and /or Is (in sterile conditions) by the terms of the MDR. This shall only apply if their existing declaration of conformity under the MDD was drawn up prior to 26 May 2020.

Those manufacturers who choose to benefit from this extension period, however, may not make any substantial changes to the design or intended use unless they comply with the MDR standard.

For the other Class I devices, however, no room for manoeuvre will be granted to manufacturers of Class I devices which will absolutely need to be certified under the MDR by 26 May 2020. In addition to this, all devices in all classes must comply with the following requirements of the EU MDR as of 26 May 2020: post-market surveillance, market surveillance, economic operator registration and device registration. Also, while Class I manufacturers did not need to have a formal quality management system (QMS) under the MDD, the MDR demands a QMS that complies with Article 10(9) of the MDR.