Ultimo aggiornamento: 26 giugno 2026
Navigare lungo il percorso verso la certificazione dei dispositivi medici in Europa è più complesso che mai. Il passaggio al Regolamento europeo sui dispositivi medici (MDR 2017/745) e al Regolamento sui dispositivi medico-diagnostici in vitro (IVDR 2017/746) ha introdotto norme più rigorose in materia di sicurezza, prestazioni e trasparenza. Ottenere la conformità all'EU MDR o all'IVDR non è più solo una questione di compilazione di moduli; richiede un approccio continuo al ciclo di vita, prove cliniche e documentazione tecnica. È qui che interveniamo noi. In qualità di consulente dedicato per l'EU MDR, Morulaa Health Tech fa molto di più che redigere semplicemente i vostri documenti; progetta la vostra sottomissione per un successo fin dal primo tentativo.
Perché collaborare con un consulente esperto in EU MDR? Il vantaggio dell'80%
To safeguard device safety, security of supply and compliance with strict biological safety rules specific packaging categories are excluded from mandatory plastic circularity targets. Article 7 states that the binding 2030 and 2040 targets for integrating minimum percentages of post consumer recycled plastic content do not apply to contact sensitive plastic packaging of medical devices devices exclusively destined for research use and investigational devices. The same exclusion applies to contact sensitive plastic packaging for in vitro diagnostic medical devices. This technical carve out ensures that manufacturers are not forced to introduce recycled polymers into medical grade plastic packaging components where doing so could compromise device performance or patient safety.
Regulatory Flexibility for Manufacturing Plant Documentation
The regulation provides operational and administrative relief specifically tailored to large scale industrial and customizable medical setups. According to Article 15 the standard manufacturer obligations to conduct horizontal conformity assessment procedures and to retain extensive technical packaging documentation for five to ten years do not apply to custom made transport packaging used for configurable medical devices and medical systems in industrial and healthcare environments. For standard non custom medical device packaging that does fall under the technical documentation scope, manufacturers or their authorized representatives must make the technical dossier available to national market surveillance authorities within 10 days of receiving a request.
Conditional Labeling Exemptions for Limited Space
Horizontal material identification and sorting rules are modified if they interfere with sector specific medical labeling. Under Article 12 the mandatory requirement to print engrave or affix harmonized material composition labels and digital open data carriers does not apply to immediate and outer packaging if there is insufficient physical space on the packaging due to overriding medical device labeling requirements. Furthermore if adding the packaging waste sorting symbols risks confusing the end user or jeopardizing the safe clinical use of the medical device the manufacturer is technically exempt from displaying them.
Heavy Metal Restrictions and Concentration Frontiers
Despite the structural and recycled content exemptions all packaging components imported or placed on the market must comply with foundational hazardous substance limits. Article 5 dictates that the sum of the concentration levels of lead cadmium mercury and hexavalent chromium resulting from substances present in the packaging or its individual components must not exceed 100 mg/kg. Compliance with this mandatory safety threshold must be technically validated and recorded in the formal documentation framework outlined in the regulation.
Jurisdiction and Escalation of Public Health Risks
The regulation establishes a clear legal boundary between environmental market surveillance and specialized medical device safety oversight. If an absolute risk to human health is detected in contact sensitive medical packaging and that risk is transferred directly to the packaged medical product or internal device components standard environmental market surveillance authorities are legally barred from executing a standalone evaluation. Under Articles 58 and 60 they must step aside and immediately alert the specialized competent authorities responsible for medical device enforcement to ensure that any corrective action product recall or medical safety investigation is handled strictly under the appropriate medical device framework.
FAQ
What are the audits or site visits required for the packaging registration?
The provided text does not contain any guidelines, rules or requirements regarding physical facility audits or site visits by country auditors for medical device manufacturing plants under this regulation.
What are the registration costs or fees for overseas manufacturers?
The document does not detail specific costs, standard tariffs or administrative registration fees applicable to overseas manufacturers or their products entering this market. under article 44 the competent authority may charge producers cost based and proportionate fees for processing applications for the packaging register but no exact financial amounts are provided in the text.
What are the timelines to submit clinical data or clinical trials?
This text does not regulate, mention or establish any timelines requirements or frameworks regarding clinical data or clinical trials for medical devices.
What are the document workflows to bridge an FDA approval or CE mark?
The provided document does not mention the US FDA CE marks or any process for converting foreign medical device approvals into local marketing authorizations.