Revaluation of old certificates
Clinical reassessment of approved medical devices with legacy certificates between 2020 and 2024
With the entry into force of MDR, the transitional period of three years provided for in the regulation began, within which manufacturers can be certified either under old law or already under new law. Products approved under old legislation and thus marketed on the market must be adapted to MDR no later than 5 years after the date of application; Following the final implementation of the MDR (expected in the second quarter of 2020), this period will be shortened to four years. This situation will allow manufacturers to extend their legacy certificates until just before 26 May 2020. These then remain valid until mid-2024 (in the case of MDD Annex IV certificates until 2023). In 2024, all medical devices placed on the market will presumably be certified according to the new EU MDR.
Reclassification of approved medical devices with old certificates
EU Regulation 2017/745 (EU-MDR) changes the classification of some medical devices according to the 22 classificaton criteria (in Annex VIII of the MDR) to the classes. Thus, individual individual software software usually falls at least in class IIa. Invasive control systems and implants often have to meet the requirements of Class III. Nanomaterials, invasive products for the insertion into the body or for the application of medicaments through body openings or for the application of the skin can also be affected.
In addition, not only manufacturers, but also suppliers, importers, distributors and distributors (the so-called "economic operators" or economic operators) often have to follow the tightened rules.
According to new MDR, manufacturers of products with legacy certificates must review the new classification rules and update their clinical assessment accordingly. When re-classified as class IIa and IIb medical devices, a systematic clinical reassessment may be necessary, if necessary. taking into account the new rules on equivalence of products and the issue of a clinical trial. In doing so, they must take into account the new wording of the Equivalence of Products Regulation, as well as facts that may invalidate a clinical trial.
The clinical evaluation office Prof. Zenner can help to exhaust the existing scope within the MDR in the practical implementation, without endangering patient safety.
Our proprietary methods of Clinical Evaluation can be found here...