CE mark is required for each medical device sold in EU. Since 26th May 2021 all new devices put on the market shall comply with the applicable requirements of EU medical device regulation. Although the transitional period can be used for current MDD certificates for Class III, Class IIb and Class IIa until 2024 and …
MDR Technical documentation requirements will be one of the main challenges for the medical device manufacturers during transition from 93/42/EEC (MDD) to EU 2017/745 (MDR). As explained on “How to CE Mark your medical device” article, preparation of the technical file is a critical milestone. Since there is no grandfathering for the devices on the …
The change journey of the EU medical device directives since 2012 was completed on 5 May 2017 with the publication of EU 2017/745 and EU/2017/746 in the EU official journal. EU 2017/746, which we are accustomed to briefly refer to as IVDR, entered into force on 26 May 2022. However, due to the COVID 19 …
EU Commission has announced EU MDR 2017/745 designation of 40th notified body (NB). The number of Notified Bodies is expected to increase with the issue of the amendment for MDR extension on 20 March 2023 .With increasing number of NBs manufacturers may find more options to certify their devices. Since beginning of 2019, when the …
Many medical device’s manufacturers have difficulties in locating a notified body for CE Marking of their products. This article provides detailed information on the notified body selection criteria which could be implemented by manufacturers who are planning to put their medical devices on the EU market. Still with 40 NBs for MDR and 10 NBs …
The increased validation requirements of MDR (EU 2017/745) bring new challenges to the manufacturers of devices utilizing software and standalone software which are considered as medical device in line with the Article 2 of the MDR. EN/IEC 62304:2006/A1:2015 is a basis standard which defines requirements for Medical Device Software Life Cycle Processes. In addition …
MDR Clinical Evaluation Requirements including clinical investigation are defined on Chapter VI, Annex XIV and Annex XV respectively. As you know, to CE Mark a medical device under MDR, the importance of obtaining clinical data and evaluation is extremely important. Especially for implantable and Class III devices manufacturers shall implement a very carefully designed PMCF …
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 …
Use of Harmonised Standards The MDCG 2021-5 Guidance on standardisation for medical devices explains the use of harmonised standards for demonstrating compliance to MDR (EU 2017/745 ) and IVDR (EU 2017/746) . Although this guidance document does not include new information, it is especially helpful for medical device start-ups and manufacturers, which are at the …
Food and Drug Administration (FDA) is the legal authority to establish rules and regulation for the use of medical devices within the United States. According to Food, Drug, and Cosmetic Act products falling within the scope of medical devices, shall be registered in FDA database. In that sense, FDA 510 K clearance is required for …