Guidance on Custom-Made Devices
The Medical Device Regulation 2017/745 defines a ‘custom-made device’ as any device which is specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications. This authorised person gives specific design characteristics provided under their responsibility. Moreover, such a custom-made device would be exclusive ...
Beware of Potential Labelling Issues
A concerned client of Advena has shared their recent audit experience with their notified body, which we believe is worth highlighting to raise awareness. The medical device manufacturer in question had recently withdrawn their UKCA certification. However, during their latest audit for CE certification, a major non-conformity was raised by the notified body due to ...
Classification Rationales
In the rapidly evolving European regulatory landscape, correct classification of medical devices and in vitro diagnostic medical devices (IVDs) under the Medical Device Regulation (MDR, EU 2017/745) and In Vitro Diagnostic Regulation (IVDR, EU 2017/746) is pivotal. Misclassification can lead to delays in market access, costly rework, compliance risks, and, most importantly, patient safety issues. ...
Guidance on Borderline Products
The Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) provide comprehensive and detailed definitions that clearly outline what qualifies as a Medical Device and an In Vitro Diagnostic Medical Device. These definitions are essential, as they serve as the foundation for determining the regulatory pathway for products within the European Union. The ...
Medical Device Definition under the MDR
As a manufacturer, it is vital to know whether your device is a medical device within the scope of the MDR as this would determine if the MDR applies to your device or not. You might think that a medical device is any product that is found in a hospital that is not a drug, ...
Article 15 of the MDR/IVDR: Person Responsible for Regulatory Compliance (PRRC) – Summary Guidance Statement.
We have heard numerous stories from around the world containing mixed messages regarding who can be appointed the PRRC of a medical device manufacturer. The following will hopefully answer the basics and we will try to keep this short and to the point. Does a manufacture need to appoint a PRRC? Yes, all manufacturers must ...
Annex XVI Devices Without an Intended Medical Purpose – Current State of Play
Annex XVI devices are devices without a medical intended purpose that are within the scope of the MDR. In the past two years, there have been a number of regulations, common specifications and guidance documents that have been published regarding these devices. This article is intended to explain the current state of play of these ...
EU Medical Device Regulation
The EU Medical Device Regulation 2017/745 (MDR) entered into force on 26 May 2017 and began to apply from 26 May 2021, superseding the EU Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD). Although there are many similarities between the two legislation, the MDR presents a key update for ...
Reusable Surgical Instruments
Considerations in the Medical Device Regulation Under the current Medical Device Directive, these devices fall under Class I, with no Notified Body (NB) involvement (unless sold sterile). Similarly, the Medical Device Regulation also classifies these devices as Class I, however will now require Notified Body involvement with respect to the following aspects relevant to the ...
Medical Device Definition (MDD/IVDD)
It is important to understand the definition of a Medical Device, or an In-Vitro Diagnostic Medical Device (IVD), as many manufacturers are confused about this, in particular in respect of products which may be regarded as borderline to a pharmaceutical, cosmetic, or to personal protective equipment. The key definitions are spelled-out within the directives and ...
