The medical devices sector in Europe is experiencing rapid growth and transformation, driven by advancements in technology, developing regulations, and an aging population. In this post, we will discuss the latest trends, developments, and innovations in the European medical devices sector and their impact on the industry’s future. Challenges and opportunities in the Medical Devices […]
Gap analysis is a crucial step for any company seeking EU EUDAMED compliance, as it serves to identify the differences between the company’s current operations and the new regulation. With realizing EUDAMED, manufacturers of medical devices will be required to comply with new regulations and requirements that will have an impact on their operations and […]
CEP/CER, PSUR, and PMCF are essential components of the regulatory compliance requirements for the medical device industry. These regulatory documents are essential for ensuring the safety, efficacy, and quality of medical devices throughout their lifecycle. According to the new EU Medical Device Regulation, the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) are mandatory […]
The Swissmedic position paper on DCTs second version was published on 15th December 2022. The Swiss Agency prepared it for Therapeutic Products (Swissmedic). In this blog, we will discuss some of the most critical aspects of this document. Introduction What is a decentralized clinical trial? A decentralized clinical trial (DCT) is a research study in […]
The EU MDR is a new addition to an already existing set of medical device regulations. Medical device manufacturers looking forward to implementing MDR must understand the changes that MDR brings with it. Moreover, they must also understand the critical differences between EU MDR and the US FDA, another renowned regulatory framework. Differences between FDA […]
The new medical device regulations by the name of EU MDR will be implemented in Europe by 26 May 2021. Article 18 of EU MDR requires manufacturers of implantable devices to send an implant card and relevant information to the patients who use implantable medical devices. Demystifying Elements of Implant Medical Device Compliance What is […]
As a part of making the regulatory process stringent, EU MDR requires all the medical device manufacturer looking to market their devices in the European market to be have their medical devices tested robustly for bio-compatiblity. The ISO 10933 can be taken as a basic standard which provides relevant guidelines and information on the products […]
The EU published its Medical Device Regulations on 25th May, 2017. The new regulations were supposed to be imposed from this year but the CoVID-19 pandemic has delayed its implementation, shifting the date of implementation to 26th May, 2021. The MDR demands that all the medical device manufacturers who want to market their products in […]
As per EU MDR Articles 13 and 14, Medical Device Importers and Distributors operating in the Europe have newly defined roles. The European Medical Device Regulation (2017/745) was released in the year 2017, a small number of medical device distributors and importers are thoughtful of the new requirements that would be applied on them. Most […]
The European Medicines Agency (EMA), which looks after the pharmaceutical sector in the market operating under European Union’s, has started to issue guidelines and explanations on Medical Devices Regulation (MDR) compliance related issues for the medical device and drug combination products having components of drug and medical device units and thus manufacturers should be aware […]
Article 15 of both the regulations the In-Vitro Medical Device Regulations (IVDR) and Medical Device Regulations (MDR) have important new requirements for hiring a ‘person Responsible for Regulatory Compliance’. With the new EU MDR 2017/745 and IVDR 2017/746, ensuring the competent personal in the right position is not only important from the business point of […]