Documentation according to the Medical Device Regulation (MDR)
A proper technical documentation according to MDR or IVDR is the basic requirement for an approval. This includes all information that describes a technical product, its use, maintenance and repair. Its structure must be designed in such a way that the respective purpose according to appendix I of the MDR (93/42/EWG) is completely fulfilled. The purpose of the technical documentation is the information and instruction of users, the manufacturer's liability insurance, product monitoring, traceability and reproducibility, as well as the archiving of information.
The draft of the EU Commission for Medical Device Regulation, MDR for short, was available at the end of September 2012. Modifications by the EU Parliament then took place in October 2013. Finally, in June 2016, a draft agreed with the European Council was submitted to the trilogue of the European Commission, the Member States and the European Parliament. The regulation has been in force since 2017. The introduction of MDR will significantly influence the approval procedure and thus the technical documentation.
Innovations in the MDR
New in MDR are prescriptions concerning non-viable human tissue products and tissue donation procedures. Now there are regulations for certain products that have no medical use. For example, for materials that are introduced into the human body for cosmetic reasons, such as hyaluronic acid for injecting wrinkles.
In addition, the monitoring of auditing and certification bodies has been strengthened by stricter rules. The goal is to review the companies that control medical device manufacturers as a notified body. The focus will be on the clinical competence of the Notified Bodies. At the same time, the notified bodies will receive new powers. In addition, they should regularly conduct non-event-related unannounced audits, with the audit team changing regularly.
Furthermore, will in the future, in addition to the authorities, further stakeholders be able to access the pan-European central data collection, the European Database for Medical Devices (EUDAMED). A worldwide uniform product labeling of medical devices, the UDI (Unique Device Identification) is introduced. This simplifies the identification and tracing of faulty products.
The requirements for clinical evaluation and testing will be tightened by more precise guidelines on how clinical data will be collected, documented and evaluated in the future. In addition, the classification of implantable medical devices or implants will be adapted and nanomaterials will be included in the data collection.
We support you in the preparation of the technical documentation considering the MDR. We can advise you on the preparation of the technical documentation as well as the creation of individual documents, such as the risk management file or usability engineering file. This will provide you with the required documents, which you can use as templates in the following approvals, allowing you to focus on your core know-how.
- complete preparation of the technical documentation
- Assistance / Consultation with your technical documentation
- Testing your technical documentation regarding the necessary requirements for approval
- revision of your technical documentation according to audit deviations
Evaluation of your existing technical documentation
A technical documentation must include all necessary requirements for the approval of the product. In case this is incomplete, or not compliant, it will result in unnecessary administrative work. Therefore, we offer you a review of your technical documentation on the basis of the important and necessary aspects.
We can test for you:
- Software life cycle according to IEC 62304
- Compliance with the basic requirements of MPG and MDR
- Risk management file
- Usability Management File