EU MDR, MedDO
The medical device sector has many challenges for manufacturers or suppliers, in Europe under Regulation (EU) 2017/745 (MDR) in the USA or in Switzerland under the MedDO.
Our experts at Axxos will help you to successfully maneuver through the requirements with clever registration strategies or find tailor-made solutions for your situation.
Whether it’s the technical documentation for CE marking in Europe, the approval of your device in Switzerland or the development and efficient introduction of a practical quality management system – Axxos will support you in all challenges.
This creates additional organizational value.
Since May 26, 2021, there is no longer an automatic mutual recognition of CE conformity between the EU and Switzerland.
Products from abroad now require a Swiss authorized representative (CH-REP) based in Switzerland when placed on the Swiss market. Likewise, medical devices from Switzerland require an EU authorized representative (EC-REP) based in the EU when they are placed on the EU market.
For both situations, Axxos cooperates with partner organizations to ensure lean, efficient and compliant processes.
Are you looking for an EC or CH-REP? Please contact us directly here:
With the Medical Device Regulation (EU) 2017/745 (MDR), the basic requirements for medical devices have become stricter. In addition, there are new specifications, structures and required content for the technical documentation. This is true for both, products that have been on the market for a long time (legacy products) or newly developed devices.
Our experts at Axxos provide support for all challenges and bring a wealth of experience from all areas and risk classes of medical devices. Competent advice, MDR-specific documentation review or a clever registration strategy – we provide uncomplicated, pragmatic help exactly where it is needed.
The clinical evaluation is an important element for the demonstration of conformity with the general safety and performance requirements of the MDR (EU) 2017/745. It examines the safety and performance of a medical device, including the clinical benefit. Undesirable side effects and the acceptability of the benefit-risk ratio are also assessed.
Together with post-market surveillance and risk management, the clinical evaluation is a central pillar during the entire lifecycle of a medical device. It is one of the most important parts of the technical documentation.
Axxos has extensive experience in performing clinical evaluations. Are you unsure whether the level of clinical evidence for your medical device is sufficient? Whether CEP (Clinical Evaluation Plan), systematic literature search or CER (Clinical Evaluation Report) – we can help quickly and reliably!
Post-market surveillance (PMS) activities have received a stronger focus as a result of Regulation (EU) 2017/745 (MDR). The requirements for the post-market surveillance plan in accordance with MDR Annex III have increased. In addition, the post-market clinical follow-up plan (PMCF plan) is a further document required. Data sources must be defined for each medical device and suitable indicators and threshold values must be specified. A PMCF study is required for some medical devices, while proactive PMCF activities are sufficient for others. Articles 85 and 86 of the MDR contain reporting requirements and the MDCG 2022-21 provides guidance on the safety report (PSUR).
Axxos supports the collection and availability of sufficient data for each medical device with as little effort as possible. Based on the requirements of the MDR, efficient processes are implemented that make it possible to learn more about the medical device, improve it and react early before serious problems occur on the market. In this way, PMS becomes an opportunity and not an unpleasant requirement of the law.
The need for safety in the healthcare sector is extremely high. Medical devices must comply with the essential safety and performance requirements of Regulation (EU) 2017/745 (MDR). A comprehensive risk management system is required, which must be implemented, applied and maintained. A clear and simple risk management system is the basis for bringing a safe and high-quality product to the market.
The EN ISO 14971 standard, which is harmonized with the MDR, provides assistance in implementing a risk management system. However, as always, the devil is in the detail.
How exactly should the acceptance criteria for residual risks be defined in the risk management plan for a specific product? How can an overview of implementation and effectiveness all control measures be maintained? How can the overall residual risk be declared acceptable in the risk management report?
It is crucial how the risk management process interacts with the processes for post-market surveillance (PMS), product development and the clinical evaluation ((link zu Independent Clinical Evaluation expertise)). Only an integrated solution can ensure that the safety requirements for medical devices are met.
Axxos has a large expertise with the diverse requirements for risk management and implements these individually for each medical device or within the complete organization.
The initial situation must be known at the start of a project. This is the only way to assure an efficient planning and implementation! Axxos supports you with preparatory audits, as-is or gap analyses.Learn more about Gap analysis and internal status audits
In the highly regulated medical device market, a quality management system to maintain product quality is generally mandatory. Axxos has many years of experience in setting up, implementing and supporting the certification of quality management systems in accordance with EN ISO 13485 and 21CFR820 (FDA) for manufacturers, distributors and suppliers.Learn more about Quality Management Services
There are many applicable laws, standards and guidance documents in the medical device industry. The Axxos update service monitors and summarizes the changes in a comprehensible annual or semi-annual report.Learn more about Update service standards and regulations
Both manufacturers and users of medical devices can be inspected by the authorities (Swissmedic, cantons) at any time. For hospitals, it should be noted that increased inspections by Swissmedic are to be expected. We therefore recommend that all medical device manufacturers, healthcare facilities, hospitals, etc. prepare systematically and specifically for an inspection in order to prevent serious consequences.
Axxos offers support in the following areas:
- GAP analysis regarding the relevant legal requirements (e.g. GPA / MedDO) to identify potential gaps
- Development of pragmatic and legally compliant solutions and support during the implementation.
- Preparation and active support during an inspection
- Supporting the follow-upactivities of such an inspection
- Ensuring the efficient and sustainable processing/elimination of identified deviations
- Supporting adequate communication with the authorities.