Technical Documentation and Medical Device Regulation: new developments
The evaluation of technical documentation (TD) by a notified body is the central element of the conformity assessment procedure towards receiving the CE mark. The entry into force of the Medical Device Regulation (EU) 2017/745 will place more emphasis on the crucial role of the TD. This article will focus on two key topics: 1. the evolution of the evaluation procedure used during the conformity assessment, and 2. new demands that the notified body (NB) might expect during the conformity assessment.
Evaluation Procedure of Medical Devices: three new practices
There are three important changes in the review process of medical devices by NB's that you should be aware of. We discuss them in the following sections.
1. ON-SITE REVIEW
The new regulation marks an end to TDs being reviewed on-site. Regardless of the class of the device or devices in question, the TD will now be reviewed and evaluated remotely by the NB. To this end, clinical evaluations will be reviewed both by a clinician from the NB, as well as by an evaluator and thus significantly prolonging the evaluation phase. For example, the clinical evaluation of a class IIa device will be reviewed for approximately 4 to 5 days.
There will no longer be nonconformities, instead, the new evaluation format will consist of "rounds" of questions from the NB that the manufacturer should answer within an agreed-upon timeframe. As such, there will be a maximum of three rounds of questions and answers. At the end of the rounds, the NB will determine the result of the evaluation as Application Accepted or Application Rejected.
3. QUALITY MANAGEMENT SYSTEM
In addition to the TD itself, quality management system documentation may be requested by the evaluator during the evaluation. Such documents may include standard operating procedures (e.g. post-market surveillance procedure) and/or records (e.g. quality control records, evidence of personnel competence, etc).
New developments to expect from NBs
The TD review will now rely on the general safety and performance requirements (GSPR) checklist as a focal point. This will allow for the NB to conduct a more comprehensive and exhaustive TD review while keeping the GSPR checklist as a reference point through the evaluation. As a result, TD reviews will be much longer given the higher level of detail and the additional number of requirements present in the GSPR list in Annex I of Regulation (EU) 2017/745. Here are some of the new developments that are identified:
Firstly, while it may always be possible to exclude the ISO 13485 QMS design and development requirements, submissions associated with the development of state-of-the-art technologies/methods will be investigated by the notified body. This may include, for example, establishing traceability matrices;
Risk analysis will be evaluated with more scrutiny and the systematic review of the evidence for product verification and validation becomes an important element of the evaluation. Documented evidence of the detailed benefit-risk analysis will now be examined in greater depth. Similarly, an in-depth examination will be done when analysing the organization's ability to determine individual risk acceptability of residual risk in terms of the associated clinical benefits;
The demonstration of the clinical benefits of the device will represent a substantial part of the evaluation. This will also apply to the clinical evaluation through the Clinical Evaluation Report (CER), as well as the post-market follow-up, the post-market surveillance, and the post-market clinical follow-up. Additionally, the procedures and processes used by the organization to guarantee the appropriate realization of these activities iteratively and continuously will be evaluated by the NB;
Organizations will be expected to implement the basic UDI-DI system for the device (this system uses a unique identification for each medical device family to facilitate registration to the EUDAMED database). As such, the basic UDI-DI will be included in the TD;
There is more emphasis on the relationship and coherence between the instructions for use (IFU) and the information in the TD, especially regarding clinical benefits and residual risks. It will also be necessary to consider the state-of-the-art with regards to labeling;
Finally, care will have to be taken when determining the representative sample size of test devices that will be used during the verification and validation activities.
It is important to have a practical approach, and in doing so, close attention must be paid to the TD submission requirements (this may vary depending on the NB). For example, you may be required to submit a translated version of your TD to facilitate review and evaluation based on the preferred language of the experts of the applicable competent authority associated with your NB. Additionally, you may need to submit your documents in a searchable file format, for example.
In conclusion, to provide you with a well-rounded outlook, this article presented a realistic implementation of what you can expect when going through a TD submission and review by your NB. However, it is important to note that these procedures are still being implemented by the various NBs and that the introduction of new guidance(s) (such as those from the Medical Device Consultation Group) is likely to result in further procedural changes.
Technical Documentation: what exactly is it?
The technical documentation contains all the medical device information throughout its lifecycle from conception to placing on the market, including all intermediate phases such as production and collection of post-market data. Despite the new requirements and procedures presented in the Medical Device Regulation (Annex II), the technical documentation's contents as a whole remain unchanged, perhaps with the only difference being a greater level of detail. Here is a general list of what must be included in the technical documentation:
information on the manufacturer and its authorised representative;
information on the medical device in question, its variants, and unique device identification (UDI);
the design file following ISO 13485 Clause 7.3.10;
information provided with the medical device (instruction for use and labeling, etc.);
information regarding verification testing of the performance of the medical device;
information on validation of the medical device including clinical evaluation;
information on verification of the safety of the medical device (e.g. biocompatibility);
risk-benefit analysis and risk management;
general requirements for safety and performance;
the list of applicable standards and directives;
Note: this article is not original work but is a translated version of the article titled "Dossier technique et RDM: les nouveaux points d'attention" written by Aymeric Lebon, General Manager at Strategiqual.