Changed requirements for accreditation in the area of medical devices
Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices is effective from 26 May 2021. Together with Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices, with its date of application following on 26 May 2022, it has implications for accreditation in the area of medical devices. In future, the requirements for accreditations in this area will essentially result from the respective underlying standards without additional sectoral requirements.
On 25 May 2017, Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 as well as Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices entered into force. While the regulation on medical devices was originally intended to apply from 26 May 2020, the date of application was postponed to 26 May 2021 due to the COVID-19 pandemic. The regulation on in vitro diagnostic medical devices will apply from 26 May 2022.
Adjustments to national medical device law
Both regulations replace the medical devices directives 90/385/EEC and 93/42/EEC as well as the in-vitro diagnostics directive 98/79/EC from their respective dates of application. They are directly applicable in the EU Member States and therefore do not need to be transposed into national law. Nevertheless, extensive adjustments to national medical device law were necessary, and were effected by means of the Medical Devices EU Adaptation Act (MPEUAnpG) and the Medical Devices EU Adaptation Ordinance.
Sectoral requirements in the area of medical devices and in vitro diagnostic medical devices
The changes in the legislation have an impact on the requirements for accreditation in the area of medical devices in 2 stages:
For accreditations in the area of non-active and active medical devices, additional sectoral requirements derived from the requirements of Directives 90/385/EEC, 93/42/EEC and the associated national legislation have thus far applied. These requirements are set out in the standard documents 71 SD 3 016 to 71 SD 3 022 among others. With the validity of the EU regulation on medical devices, these additional requirements no longer apply.
In contrast, the regulations for in vitro diagnostic medical devices, which are derived from Directive 98/79/EC and the associated national legislation, will no longer apply one year after the date of application of Regulation (EU) 2017/746 on 26 May 2022. The rules for certification bodies for quality management systems in accordance with the DIN EN ISO 13485 standard will also remain in force until this date. For this reason, the standard documents 71 SD 3 016 to 71 SD 3 022 remain available on the DAkkS website.
Accreditation standards decisive
With the changeover, the requirements for accreditation in this area are essentially derived from the respective underlying accreditation standards: DIN EN ISO/IEC 17025 for testing laboratories, DIN EN ISO/IEC 17021-1 for certification bodies for management systems and DIN EN ISO/IEC 17065 for certification bodies for products. Accreditation certificates containing a reference to directives 90/385/EEC or 93/42/EEC are automatically adapted by Deutsche Akkreditierungsstelle (DAkkS) within the framework of the ongoing case. DAkkS would like to point out that no action on the part of the conformity assessment bodies concerned is required.
