After the issue of implementing regulation for the reprocessing of single-use devices, EU Commission issued the implementing regulation 2022/2346 as regards common specifications (CS) for the groups of products without an intended medical purpose listed in Annex XVI of EU 2017/745 MDR. The manufacturers who aim to produce the products covered by Annex XVI …
PMCF (Post Market Clinical Follow-Up) is maybe one of the most challenging new MDR (EU 2017/745) requirements. As many of you know, MDR has increased requirements for clinical evaluation and market surveillance. The importance of the clinical data shows its effects for post market surveillance as a more detailed PMCF process. Of course this shall …
Implant card (IC) is one of the new requirements of the MDR – EU 2017/745. The requirements specified in Article 18 will bring new challenges to the daily life of the implantable device manufacturers. The guidance MDCG 2019-8 includes useful hints, which will help the manufacturers during design of an IC. Before diving into details …
The EU Commission has issued guidance documents for Medical Device Software within the scope the EU 2017/745 MDR and EU 2017/746 IVDR. The first publishment related with MDSW is MDCG 2019-11, contains information on the qualification and classification of medical device software. The second one is MDCG 2019-16 which is a guidance document on Cybersecurity for …
MDR Transitional Period The guidance document for the implementation of Article 120, which many companies plan to use during the transition to MDR EU 2017/745, has been published. The main requirements for the validity of the 93/42/EEC and 90/385/EEC certificates after May 2021 can be summarised as; The guidance includes a paragraph about the surveillance …