Insights, guides, and news related to the medical device sector

The hierarchy and comprehensive overview of MDR regulatory sources: regulations, EU acts, MDCG, CS, harmonized standards, and the state of the art.

Analysis of the new EN ISO 10993-1:2025 on biological safety, alignment with ISO 14971, and impact on documentation and testing.

Critical analysis of ministry guidelines on complaints and incidents: conceptual errors, MDR risks and regulatory non-compliance.

Published in the Official Journal the notice of full functionality of four Eudamed modules. Registration becomes mandatory.

With Regulation (EU) 2025/1234, all devices intended for professional users can have electronic instructions for use.

The use of equivalent spare parts not produced by the original device manufacturer is acceptable. Rules for manufacturers.

The responsibilities of platforms (such as App Store and Google Play) and MDSW manufacturers for the online distribution of medical apps.

The clear definition of useful life and its various interpretations for each type of device (active, software, single-use, implantable...)

Class I devices without a UDI code on their label are no longer compliant with current regulations.

Guidelines for proper qualification and classification of telemedicine software according to MDR and MDCG 2019-11.

A detailed analysis of the conditions that impose additional duties, beyond standard obligations, according to MDR.

The NIS2 Directive imposes cybersecurity obligations on medical device manufacturers that are medium and large enterprises.

Insights into the regulation of medical devices with integrated AI-based functions.

Guidelines for UDI affixing process verification and validation obligations and our complete and compliant printing system.

The Ministry of Health has defined mandatory actions for updating legacy device registrations in the database.

Details of the new MDR-compliant implant card production and printing service for manufacturers of implantable medical devices.

The complete guide for healthcare providers and dentists for mandatory registration and storage of UDI codes from January 15, 2024.

The 5 less obvious aspects, ranked by impact, to manage in order to complete the MDR conformity assessment process.

We share the high-level scheme applied to our clients: the most straightforward approach to post-market surveillance.

The recent extension of the MDR has raised several questions. This article provides answers to the most common ones.

All the details regarding the UDI code for medical devices, issuing bodies, and methods of obtaining and applying.

All the steps to independently register UDI codes of medical devices in Eudamed, the European database.

The European Commission has accepted the proposed MDR extension. MDD certificates remain valid beyond their expiration date.

All the steps to independently register an economic operator in Eudamed, the medical device database.

The European Commission is voting on a further postponement of MDR applicability to 2027/2028 for medical devices.

Concerns about the disruption in the supply of medical devices are well-founded. The MDR is the cause, and now a solution is being sought.

EN 60601-1-2/A1:2021 impacts type tests, and its implementation may require repeating or performing certain tests.

By April 30th of each year, it is mandatory to declare promotional activity expenses and pay the 5.5% contribution to the Ministry.

MDCG 2022-11: manufacturers are not sufficiently prepared, if they don't hurry up, shortage of medical devices.

A new circular from the Ministry defines the methods for medical device vigilance while waiting for Eudamed to become operational.

Regulation 2017/745 (MDR) defines the dates for compliance with the requirements for obtaining and applying the UDI code.

After the latest modification to the medical devices database, action is required to update existing registrations. The details.

Articles 13, 14, and 16 of the MDR, applicable to distributors and importers, and obligations in case of relabeling and repackaging.

The latest Eudamed update allows for the registration of medical device UDI codes. How to access the registration module.

There are very few standards harmonized with the MDR. A guide to choosing the most coherent ones and future harmonization timelines.

While waiting for Eudamed, registration in the Ministry's database remains mandatory. This includes devices under MDR.

Unrecognized certificates and mandatory authorized representative: the severe consequences of failing to update the Mutual Recognition Agreement.

According to Article 10 of the MDR, manufacturers must compensate for damages from defective products and have sufficient financial coverage.

The difference between placing on the market and making available, to clearly define when to adapt devices to MDR.

The unique, publicly accessible database providing an up-to-date picture of the lifecycle of medical devices in Europe.

A series of concepts to approach the problem of searching for and choosing standards to apply with greater confidence.

The European Commission has decided to adopt the Italian National Classification of Devices as the official nomenclature in Eudamed.

The Medical Device Regulation (MDR) establishes the new European rules for conformity assessment. The key steps.

Clinical investigation is not mandatory if a contract is made with the manufacturer of an equivalent device. For all classes?

Manufacturers, authorized representatives, system and procedure pack producers, and importers must register in Eudamed's Actor registration module.

The official link to Eudamed, the medical device database, has been published on the European Commission's website.

Quality system, technical file, and notified body. The details of how to obtain CE marking for a medical device.

The difference between DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record) and the documents that compose them.

The logical flow of EN 14971, to address medical device risk management correctly and knowledgeably. In 4 points.

Key aspects for producing, importing, distributing, or purchasing protective masks during the COVID-19 emergency.

Advertising for medical devices must be authorized by the Ministry of Health: costs, timelines, rules, and validity of the authorization.

Aspects to consider when importing medical devices from non-EU countries for the COVID-19 emergency.

The European Commission proposes postponing the medical device regulation. The content of the proposal and the new dates.

In an attempt to clarify, an overview of UDI requirements (UDI-DI, UDI-PI, and basic UDI) for medical devices.

New compliance dates for reusable surgical instruments in the latest amendment to the medical device regulation.

Even Class I reusable surgical instruments must be evaluated by the notified body, according to MDR.

A classification rule applicable to all medical device software stipulates that these fall at least into class IIa.