[WHITE PAPER] MDR Compliant Technical Documentation
This downloadable white paper co-authored by Medidee and BSI, one of the largest Notified Bodies, gives manufacturers an interpretation of how the changes necessary for the move from compliance with the MDD/AIMDD to the MDR might be implemented, as well as practical hints on what needs to be considered in order to maintain technical documentation as stipulated by the MDR. Although being issued back in 2019, its content remains widely relevant and applicable when it comes to the constitution of MDR-compliant Technical Documentation.
As a Manufacturer, you may have wondered how to ensure your Technical Documentation Complies with EU Medical Device Regulation 2017/745. Indeed, before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant legislation.
Technical documentation had to comply with the Medical Devices Directive (MDD) 93/42/EEC or the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC (referred to as ‘MDD/AIMDD’ hereafter).
Since 26 May 2021, manufacturers willing to obtain or renew a CE certificate or to issue a Declaration of Conformity (DoC), are required to have their technical documentation compliant with the Medical Device Regulation (MDR) European Union (EU) Regulation 2017/745 (referred to as ‘MDR’ hereafter).
However, as indicated in Article 120 of the MDR, after 26 May 2021, medical devices can still be placed on the market under the provision of the MDD/AIMDD, providing the certificate was issued prior to this date, that manufacturer continues to comply with either one of the directives and that no significant changes are made in the design and intended purpose of the device.
But Manufacturers of such devices will also have to meet other requirements, which are detailed in Article 120 of the MDR and referenced in this white paper. The certificates issued in accordance with MDD/AIMDD after 25 May 2017 remain valid until reaching their expiry date, but in any case, they become void latest on 27 May 2024.
This necessitates changes for the manufacturers, Competent Authorities (CAs) and Notified Bodies (NBs) on how the technical documentation should be developed and handled.
As mentioned in the first paragraph from Annex II of the MDR, ‘the technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex’.
Reading the MDR it becomes evident that the requirements for technical documentation have been raised and will also be subject to more scrutiny by the CA/NB as appropriate.
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