The US Food and Drug Administration (FDA) has published two new draft guidance documents for public comment before 26 July 2021. The first is titled ‘Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry and Food and Drug Administration Staff’, available from here. This draft explains that…
Unique Device Identification (UDI) requirements have been introduced under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which become applicable from 26 May 2021 and 26 May 2022 respectively. The UDI system enhances the identification of medical devices and makes it easier to trace them when…
The European Medicines Agency has updated its 2015 Question and Answer guidance document on the combination product consultation procedure to align its content with the requirements of the Medical Device Regulation (MDR, 2017/745). The document has the catchy title of ‘Questions & Answers on the consultation procedure to the European Medicines Agency by notified bodies…
Eurofins Expert Services Oy, located in Finland, has become the twentieth Notified Body (NB) to be designated under the EU Medical Device Regulation (MDR, 2017/745) according to the NANDO database. Eurofins is Notified Body number 0537 and remains designated under the Medical Device Directive (MDD, 93/42/EEC) and In Vitro Diagnostics Directive (IVDD, 98/79/EC). The European…
The US Food and Drug Administration (FDA) has launched a new webpage aimed at providing support and advice to medical device manufacturers on the steps needed to demonstrate device biocompatibility in submissions to the Agency. The website introduces the subject by stating: “These resource pages are intended to explain terms and concepts important for the…
The European Commission’s Medical Device Coordination Group (MDCG) has issued a new guidance in the form of a Q&A document, introduced as being a “high-level document aimed at addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU) 2017/745 on medical devices (MDR)”. The document is titled MDCG 2021-3 ‘Questions and Answers…
The US Food and Drug Administration (FDA) is building a secure, web-based tracker that displays the Center for Devices and Radiological Health’s progress on medical device submissions focused on premarket review. The progress tracker is the first feature of a larger platform to help FDA collaborate with the medical device industry. FDA is currently seeking…
The International Standardisation Organisation (ISO) has now published a new standard in the biocompatibility series ISO 10993 that specifies the use of laboratory-grown skin for irritation testing, as an option to animal testing. The new standard is ISO 10993-23:2021, titled ‘Biological evaluation of medical devices — Part 23: Tests for irritation’, which replaces the irritation…
The Medical Devices Coordination Group (MDCG) has published a 31-page document, MDCG 2021-1, titled ‘Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional’. Interestingly, the first page states: “The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission.”…
The European Commission has published a new guidance document titled ‘Management of Legacy Devices, MDR EUDAMED‘, explaining “how Legacy Devices will be identified in EUDAMED and the way the different Unique Device Identifiers for the Legacy Devices will be generated/assigned”. The document clarifies that “Legacy Devices are defined as Medical Devices, Active Implantable Medical Devices…
