Linked to the fight against covid-19, the new European regulation for medical devices has been postponed by one year and will come into force on May 26, 2021. The compliance plan will be spread over several years, up until 2025. Particularly for medical devices already on the market, this leaves some time for adaptability to update the quality management system. The implications of this regulation change are numerous, and it is essential for medical device manufacturers to adapt as quickly as possible.
This new regulation aims to standardize the legislation on the marketing of medical devices between the members of the European Union. It aims to bring new rules, a strengthening of the scope of post-marketing surveillance and control as well as an expectation on the traceability and the impact of the materials and substances used, in particular on the subject of physicochemical characterization.
The impact of this new regulation pertains mainly to the Quality Management System (QMS or QMS) of manufacturers of medical devices and therefore requires new justifications from notified bodies in order to obtain the European CE conformity marking. In France, the notified body is the GMED, and the competent authority is shared between the ANSM and the DGCCRF.
We will see in this article what are the major changes and how to comply with this new regulation on medical devices.
QMS compliance to date (ISO 13485)
Since 2016, date of the last version of the standard, the quality management system for manufacturers of medical devices has gone through ISO 13485 certification. Not compulsory, but covering the design of the MD through to recycling, this certification ensures reliability in terms of safety and quality of the MD by an organization which regularly audits the manufacturer. This ISO standard is based on the ISO 9001 standard but applied to the MD industry (for more information on the ISO 9001 standard, we have devoted an article to it here).
The fields of application of this standard are as follows:
- Management of resources related to the manufacture of the MD
- Risk management (in particular bio-compatibility, on which we have devoted an article here).
- Clinical trials and long-term quality control of MDs
- The organization of materiovigilance
- Post-marketing surveillance (in particular, the traceability of each MD issued)
- Management of CAPA procedures
The ISO 13485 certification remains effective even after the new RDM is introduced, and it is interesting to note that this facilitates CE marking and regulatory compliance. Thus, if an MD manufacturer is already ISO 13485 certified, the scope of RDM will be partly covered by this standard. There will still be some actions required on certain quality management points that we will see later.
What are the main changes and challenges related to this regulation change (EU) 2017/745?
To summarize this relatively dense regulation, we can define the main changes to the quality management system as follows:
Ensuring compliance with the regulations involves monitoring the compliance of the MD before marketing. Therefore, the establishment and compliance with a health control plan is essential. The PMS makes it possible to ensure and justify the hygiene and health safety of its MDs with regard to physical, chemical, and biological risks. Thus, this PMS takes into account the implementation of procedures on good hygienic practices (disinfection, cleaning, etc.), the analysis of risks or non-conformities, but also the justification of these procedures (traceability, 8D, DMAIC, etc. ).
Finally, the information and data from the QMS should be integrated into EUDAMED, the European database on medical devices. All database functionality will be available by May 2022, and EUDAMED will facilitate RDM certification, provided all quality data is integrated into the database.
It will also be necessary for MD manufacturers to conduct internal audits on quality and compliance with procedures. Having an up-to-date technical documentary repository will facilitate the implementation of these audits.
Towards a digitalization of QMS
The justification of all the procedures and requirements of European regulations highlights the need for MD manufacturers to digitize their quality management system as quickly as possible. Indeed, the new European regulation on medical devices involves action on many quality scopes, as well as justification from certification bodies. There are software solutions such as TEEXMA® Quality that will greatly facilitate compliance with this new RDM.
The company BASSETTI with its Technical Expertise Management is committed to implementing methods, tools and IT processes to structure, archive and disseminate this knowledge with high added value within the company.
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