Cubicdesignz

05Feb 2024

Regulations, Swiss Cubicdesignz Comments: 0

Implant Card for Switzerland

Implant Cards in Switzerland For implantable products, the manufacturer must provide the product information required under Article 16 of MedDO, the information required under Article 18 paragraph 1 EU-MDR and must include the implant card. In Switzerland, the implant card must be in all three official languages of Switzerland. The information regarding implant card is in MedDO Article 20 Information on implantable devices. Healthcare institutions must enter the details of the implant...

05Feb 2024

EU, Regulations Cubicdesignz Comments: 0

Electronic Instructions For Use Of Medical Devices

Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices was published on 9 March 2012 and came into effect on 1 March 2013. There are 10 articles in this regulation. It establishes certain requirements for the “instructions for use” for the user that must be noted by the manufacturer of the device, to ensure proper and safe use of the device as well as to know about the precautions while using the device. It is meant to reduce potential risks as much...

05Feb 2024

EU, Blogs, Regulations Cubicdesignz Comments: 0

EU Requirements for Translations

Under the Medical Devices Directive (MDD), it is required that manufacturers have translations of the technical documents like Instructions for Use. However, this rule wasn’t strictly followed up until MDR was brought in place. The European Union’s language requirements information can be found in Article 41 and Annex 1 (Chapter 3) of the EU MDR. Language requirements: EU Requirements for Translations As per MDR 2017/745, the information provided with medical devices needs to be tr...

05Feb 2024

EU, Regulations, Swiss, UK Cubicdesignz Comments: 0

UDI DI

UDI-DI On 5 May 2017, the EU published the new EU MDR 2017/745 and IVDR 2017/746 regulations in which they formally introduced the UDI system in the EU. The UDI comprises the following components The Basic UDI-DI is a technique introduced by the EU for linking medical devices to their regulatory documentation so that the model of the product can be uniquely identified throughout its entire lifecycle. The linked documentation may include the declaration of conformity, notified body certificates,...

05Feb 2024

EU, Regulations Cubicdesignz Comments: 0

In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746

The IVD medical devices Regulation (EU) 2017/746 (IVDR) brings EU legislation into line with technical advances, changes in medical science, and progress in law-making. The new Regulation creates a robust, transparent, and sustainable regulatory framework recognised internationally, improving clinical safety and creating fair market access for manufacturers. In contrast to the previous Directive, the new Regulation is directly applicable and does not need to be transposed into na...