ISO 14644-4 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up has been revised. ISO made some changes by renewing the standard, which was first published in 2001, at the end of last month. The main changes in the new version are as follows: 1. The normative content has been expanded;2. Added …
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 …
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 …
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 first module of the EUDAMED (European Databank on Medical Devices ) is live as of 1st December of 2020. This will enable economic operators to get a Single Registration Number (SRN). MDR Registration Requirements As you know, Chapter III of the MDR EU 2017/45 deals with identification and traceability of medical devices including registration …
Single use medical device reprocessing has always been a challenge for many health institutions. The new medical device regulation (MDR) EU 2017/745 defines requirements for “single-use devices and their reprocessing” in Article 17. On 19th of August 2020, EU commission issued the implementing regulation 2020/1207 as regards common specifications (CS) for the reprocessing of single-use …
The EU Commission issued Q&A document for Unique Device Identification (UDI) System. This guidance document gives an overview of the new UDI system and obligations of operators, which have to be fulfilled to CE Mark a medical device. For other details you can check our article “How to CE Mark a Medical Device” The UDI …
The MDCG issued MDCG 2020 -13 guidance for notified bodies (NB) specifying a template to be used during auditing the clinical evaluation (CER) of manufacturers. Although the guidance document is intended for the NB’s, manufacturers can benefit from it during preparation of the clinical evaluation report template. CER is a core requirement of the Medical …
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 …