Regulations

Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturer Responsibility Mutual Recognition Agreement (MRA) between EU and Switzerland: Possible situations Depending on the terms of MRA, this situation will exempt the manufacturer from EU member states from the Swiss Authorized Representative(AR) requirement. European AR will be accepted as same as Swiss ARs and vice versa. Manufacturers outside the EU and Switzerland will still ne...

Responsibilities of EU Authorised Representative • When a device manufacturer is established outside of the European Union, the manufacturer needs to appoint an authorised representative to place the medical device in one of the member states. An Authorized Representative is any person naturally or legally established in the European Community who can act on behalf of the manufacturer. • A written mandate/letter designating an authorised representative for a medical device manufacturer is ma...

After Britain leaving the EU, there have been many changes in the regulations regarding medical devices. An example of this is the UK’s Declaration of Conformity. UK Declaration of Conformity (DoC) is a technical document that products with UKCA marking should possess. The information needed on the Declaration of Conformity (DoC) is largely the same as what was required on an EU Declaration of Conformity. According to UK’s guidance on UKCA marking, manufacturers are recommended to keep...

Technical documentation should contain details of the medical device in a clear, organized, readily searchable and unambiguous manner. It should be provided with all medical devices irrespective of the device class and to be kept updated throughout the product life cycle. Technical documentation is to be prepared according to the requirements given in Annex II of EU MDR 2017/745. Requirements of Technical Documentation as per Annex II Device Description and Specification, including variants...

The SaMD definition statement should include a clear and robust statement about intended use, including the following: The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. SaMD is software that carries out one or more medical tasks. If it might be incorporated with a piece of hardware, the software performs a medical function. The international me...

FDA –Food and Drug Administration The revolution in the digital sector has resulted in the Internet of Things (IoT), Software as a Medical Device (SaMD), Internet of Medical Things (IoMT) and other connected devices permeating the healthcare environment, both in hospital and home, has ended up with the possibility of cyberattacks and intrusions against the connected medical devices and the networks to which such a device is connected. Most Medical devices are connected to the Internet, hospita...

Article 61 Clinical Evaluation The MDR reinforces the clinical data and evaluation process (article 61 and Annex XIV), and the manufacturer must confirm the device’s conformity to fundamental health and safety requirements using reliable clinical data and evaluation. The clinical evaluation establishes the device’s safety and capacity to fulfil its intended function. It also evaluates adverse side effects and determines whether the benefit-risk ratio is acceptable. Manufacturers must plan, c...