UK RESPONSIBLE PERSON
The transition period for the United Kingdom to leave the European Union is coming to an end on 31 December 2020. After this date UK will be considered a third country if no deal is reached.
It implies that if you are a manufacturer outside of UK, you need to appoint a UK Responsible Person when your products are placed on the UK market.
Our company with extensive experience in EC Rep services has expanded their officesto assist our clients also offering the service of UK responsible person.
The UK Responsible Person will act on behalf of the manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the
Great Britain market. UK Responsible Person will need to be included on product labelling.
All medical devices, including in vitro diagnostic medical devices need to be registered over the new basis, nonetheless the MHRA has established different grace periods depending on the product classification.
For more information, please don´t hesitate to contact us.
SWITZERLAND RESPONSABLE PERSON
However, this has recently changed. Switzerland and the EU have not renewed the mutual recognition agreement (MRA) governing CE marked products. This has implications for medical devices. From 26 May 2021, European manufacturers who want to place their medical devices on the Swiss market have to meet additional requirements: European manufacturers who want to place a medical device on the Swiss market have to appoint an Authorised Representative domiciled in Switzerland or CH-REP. The details of this representative in addition to the “CH-Rep” symbol must be included on the product labelling.
We at CMC have expanded our offices in order to be able to continue to support our customers in the Swiss market.
As CH-Rep, we will be the contact point for the Swiss authorities (Swissmedic). We will act on behalf of the manufacturer to carry out specific tasks in relation to thier obligations.
We put all our expertise at the disposal of our clients to guide them through this process.
The Swiss regulations have provided different deadlines for all actors to adapt to these changes.
CMC Medical Devices will help you to be ready so that you will not encounter any obstacles to market your products in Switzerland.
You can click on the map below for more information or you can also contact us. We will be happy to assist you.
Free sale Certificates
What is? Certificates of Free Sale or FSC, is an international document used to export medical devices and IVD products. It indicates that your products are marketed in Europe and can be freely sold with no limits to their exportation.
The FSC is required to export medical devices and IVD products in certain countries. This document acts as proof that your goods meet European regulations and are eligible for export. This certificate is used in the registration or renewal of the registration in non-European countries.
Not all FSC have the same acceptance rate by the competent authorities in some importing countries. Thus is important that your FSC is issued by a reference country. Spain is one of the so-called “reference countries” and all our certificates have been always admitted making new markets available to our customers