We hope you are safe and well as you read this update regarding BSI’s Technical Documentation (TD) assessment processes. TD assessment is a critical element of conformity assessments under both the Directives and Regulations. However, the Medical Device Regulation (MDR) EU 2017/745 and In Vitro Diagnostic Regulation (IVDR) EU 2017/746 have significantly increased requirements related to TD compared to the Directives. We would like to communicate some important changes in BSI processes associated with TD reviews and provide additional guidance for the preparation of Technical Documentation.
The first message we would like to share is that the assessment of TD is fundamentally different between the Directives and the Regulations; this is especially apparent for the lower-classification devices (Class B and Class C under IVDR; IIa and IIb under MDR). We recommend that you read the IVDR and MDR to complete a gap analysis for your products to identify areas that are of focus for you. BSI has published several whitepapers to support your understanding of the IVDR and MDR; the complete catalogue is accessible from our whitepaper homepage.
The IVDR and MDR require the same depth and extent of TD assessment for ALL classifications of device. MDCG 2019-13 Guidance on sampling of IVDR Class B / Class C devices and MDR Class IIa / Class IIb for the assessment of the TD, dated December 2019, states:
The depth and extent of the technical documentation assessment of Class IIa / IIb and Class B / Class C devices will be the same as the depth of assessment carried out for Class III and Class IIb implantable and Class D devices.
This means that the technical documentation of a device shall be assessed against all General Safety and Performance Requirements (Annex I) and requirements of Annex II and III. Records of the assessment shall be prepared, which allow a third party to understand the functionality of the device and all aspects of the assessment including judgements made by the assessor.
It should be considered that every device (i.e. Basic UDI-DI) might include different variants, models or sizes. In that case, the review of the technical documentation will also include the assessment of how the differences among these have been addressed in the technical documentation and whether all of them are in line with the relevant requirements.
Limit to three rounds of questions
As part of the designation process, all notified bodies, including BSI, are required to hold a clearly defined TD review process. One of the main concerns of the Designating Authorities associated with TD reviews is the risk of consultancy that may be introduced by multiple rounds of questions from the Notified Body. To mitigate this risk, BSI’s TD review process under the IVDR and MDR will be limited to three rounds of questions per submission. If multiple reviewers are involved in the assessment due to the nature of the device, each reviewer can ask and will be limited to three rounds of questions.
- If any unsurmountable gaps are identified during the review process or if gaps in the TD remain unaddressed at the end of the three rounds of questions, these will be identified as deficiencies, leading to refusal of the application for the subject device(s). In such cases, BSI recommends that the manufacturer take the commensurate amount of time to thoroughly address the deficiencies before reapplying
- If all the gaps identified are addressed within three rounds of questions, then a recommendation for certification will be made in the context of TD assessment.
Introducing the Completeness Check and updated Best Practices Guidelines
Incomplete TD submissions from manufacturers are one of the most common reasons for questions being raised by our Notified Body reviewers and ultimately can lead to delays in the assessment of TD and the certification process. To make the process more efficient for you and to ensure that we receive a full and thorough submission, we are introducing a new Completeness Check. The Completeness Check is the first step of the TD assessment process before we progress and commence a full in-depth review of the TD, which will be limited to three rounds of questions. The Completeness Check does NOT count as one of the three rounds of questions. However, failure to provide a full set of TD after two attempts may lead to refusal of the application for the subject device(s).
Please note: under exceptional circumstances, BSI may exempt the Completeness Check, this will be at our discretion.
We have updated our IVDR and MDR Best Practices Guidelines (BPG), which incorporate all the changes described above and provide further guidance for you in preparing and structuring TD. The BPGs also offer guidance on all the items listed in the Completeness Check. Following the principles laid out in these BPGs in preparing and submitting your TD will ensure a thorough and complete submission to BSI.
We strongly encourage you to work through this document before submitting your TD to BSI.
Will assessments change under the Directives?
TD assessment under the Directives will continue as per the current processes for Class IIa and Class IIb devices covered by quality system-based Directive certificates. For devices covered by product-based Directive certificates (IVDD List A devices, AIMDs, Class III, and Class IIb devices that involve a Type Examination in the route to conformity), the review process will be limited to three rounds of questions as described above starting from 2 June 2020. Although not compulsory for the Directives BSI recommends you use the Completeness Check for the Active Implantable and Medical Device Directives (please note: this is not recommended for the IVDD due to the significant difference between the Directive and the Regulation). While the Best Practices Guidelines focus on IVDR and MDR, they can be used for preparing TD under the Directives by disregarding the Regulation specific requirements.
Please contact your scheme manager if you have any queries and to obtain a copy of the Completeness Check.
Dr Jayanth Katta
Regulatory Lead, BSI Notified Body