The transition period for the IVDR has now begun. The initial timeline for date of application, on 26 May 2022 (after which, no new IVDD certificates can be issued), has been partially extended to allow manufacturers to continue to sell “legacy” devices already placed on the EU market for up to an additional 5 years, depending on the risk class, as long as no significant changes are made to the device design or intended purpose. Any new devices placed on the market will need to conform to the revised rules of the IVDR ..read more

Changes introduced in the instructions for MDSAP audits The Medical Device Single Audit Program (MDSAP) was developed to conduct regulatory audits of quality management systems (QMS) of manufacturers of medical devices. The MDSAP allows a single audit conducted by a recognized Auditing Organization (AO) to cover the requirements of BS EN ISO 13485:2016, together with specific regulatory requirements for the participating jurisdictions – Australia, Canada, Japan, Brazil and USA. Participation in the programme should reduce the need for duplicate audits and reduce the resource requirements on Re ..read more

Extension to EU Directives certificates will also apply in Great Britain and Northern Ireland To maintain patients’ access to a wide range of medical devices while ensuring the transition to the new regulations, the European Union has taken action to extend the validity of certificates issued under the Medical Devices (Directive 93/42/EEC) and Active Implantable Medical Devices Directives (Directive 90/385/EEC). The changes have been implemented by Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as reg ..read more

The Technical Committee responsible for standards on sterilization and washer disinfectors, ISO TC 198 – Sterilization of health care products – has a portfolio of standards that cover validation and routine control of sterilization processes, general requirements for sterilizers and standards for washer disinfectors. On January 2021, the committee published its first standard for sterilizing equipment; ISO TS SO/TS 22421:2021 - Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities ..read more

The European Commission’s Medical Device Coordination Group (MDCG) survey on notified body certification and application activities under the Medical Devices Regulation (EU 2017/745) (MDR) and In Vitro Medical Devices Regulation (EU 2017/746) (IVDR) showed the problems in the transition to the MDR and IVDR. A significant number of certificates for legacy medical devices expire on 26 May 2024 ..read more

European Commission set to add to list of Harmonised Standards in the Official Journal Harmonized European Standards have an important, specific role in supporting the European Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). Article 8 of each Regulation indicates, that Harmonized Standards referenced in the Official Journal (OJ) of the European Union, provide a presumption of conformity with relevant requirements of the Regulation covered by those standards or applicable parts of standards. The presumption of conformity also applies to system or process re ..read more

The IVDR shares many of its new features with the MDR (EU regulation 2017/745). Apart from the new elements shared with the MDR and the consequences for the market entry and surveillance (like the new supply chain regime, use of unique device identifiers (UDI) and a central database that is the European database on medical devices (EUDAMED)), there are three major reforms in the IVD field ..read more

European Commission propose action as survey indicates that large majority of MDR certificates expire in 2024 The European Commission’s Medical Device Coordination Group (MDCG), has undertaken a survey to collect data on notified body certification and application activities under the Medical Devices Regulation (EU 2017/745) (MDR) and In Vitro Medical Devices Regulation (EU 2017/746) (IVDR ..read more

The risk management process described in BS EN ISO 14971 [1] consists of several steps, as illustrated in Figure 1, which apply to the design, development, production and post-production stages of every medical device. The distinct process steps are numbered from 1 to 6 and discussed in detail in this paper ..read more

BS EN ISO 14971 [1] provides a generic process for risk management of all kinds of medical devices, applicable to the entire life cycle from design and development through production and postproduction until decommissioning and disposal ..read more