BSI Compliance Navigator: latest white paper- Implementing the European Union Medical Devices Regulations

The European Union (EU) Medical Devices Regulation1 (EU 2017/745) (MDR) and the In Vitro Diagnostic Medical Devices Regulation2 (EU 2017/746) (IVDR), now apply. Important terms used in the regulations are ‘entry into force’ and ‘date of application’. The publication of the text in the Official Journal of the European Union was on 5 April 2017. The ‘entry into force’ was the date when each regulation came into effect, twenty days after publication. The ‘date of application’ reflects the date from which the requirements apply and the Active Implantable Medical Devices Directive (AIMDD - 90/385/EEC), Medical Devices Directive (MDD - 93/42/EEC) and In Vitro Diagnostic Medical Devices Directive (IVDD - 98/79/EC) were repealed.

Since the publication of the legal texts, there have been corrigenda issued. These correct small errors and amendments that have been made to change the date of application and transitional arrangements. The changes in dates are in response to the challenges created or exacerbated by the COVID-19 pandemic impacting on manufacturers’ ability to undergo conformity assessment of technical documentation. These challenges include limited notified body capacity, particularly for the IVDR, and limited availability of guidance documents.

The transitional arrangements for the regulations allow for medical devices and in vitro diagnostic medical devices (IVDs), with valid certificates or declarations of conformity to the Directives, to continue to be placed on the market for finite periods. These periods depend on the classification of the device or IVD. For all classes of devices and IVDs, there are three provisos to the extension of validity of certificates or declarations of conformity.

• Firstly, that some requirements of regulations will apply to devices with valid certificates and declarations of conformity under the Directives. These requirements include those for post-market surveillance (PMS), vigilance reporting, market surveillance by national authorities and registration.
• Secondly, that no significant changes are made to the device or intended use.
• Thirdly, that the notified body that issued the certificate continues to be responsible for surveillance of devices it has certified

Download this white paper today to learn about Implementing the European Union Medical Devices Regulations.