Turkey has provided practical steps that medical device companies can take to mitigate the effects of a no-deal Brexit. It also predicts the agreement of a transition period spanning 1-2 years.
The Turkish Medicines and Medical Devices Agency (TMMDA) has published a Memorandum providing advice to medical device companies in the event of a no-deal Brexit.
It suggests that the below preparations should be made:
“For health care service providers, research institutes and health insurance companies:
- An inventory should be created regarding trade volumes within the UK in the field of medical devices, for the devices are required to obtain an EC certificate from an NB located in the UK or which devices are marketed by a UK-based manufacturer.
As to the manufacturers, authorised representatives and distributors:
- Manufacturers of devices that have received a conformity assessment service from an established NB company in the United Kingdom must be prepared to transfer the product files from another country to the EU or another accredited NB.
- An addressee who wishes to get delivery messages regarding the manufacturers of third countries that place their products in the UK or EU through a representative or importer in the UK must also appoint an authorised representative in the member states or Turkey. The label of the product should also be reprinted accordingly.
- Manufacturers transferring the certification of their products from an NB to an EU / Turkey in the UK should reorganise the EU declaration of conformity and the notified body certificates accordingly. The documents in question must show that the responsibility is in the new NB and should contain both the old and new NB’s info and numbers.
- It is the duty of suppliers, wholesalers and medical device purchasers to inform healthcare providers and other users of medical devices about potential alternatives and problems that may be encountered in supply and presentation to the market. The best information on medical devices or devices that are subject to a resident NB inspection in the UK that are put into EU market from the United Kingdom or third countries via the UK should be found in suppliers, wholesalers, and medical device purchasers”
Further, notified body transfer should follow the below guidance:
- “If certified by the 0086 numbered British Standard Institute (BSI) Assurance UK Ltd, the EC certification will be transferred administratively to the 2797 numbered notified body BSI Group The Netherlands B.V.
- If certified by the notified body other than 0086 numbered British Standard Institute (BSI) Assurance UK Ltd, medical device companies will transfer their products to another notified body that is not resident in the UK”
The TMMDA foresees a transition period of 1-2 years with regards to notified body transfer, re-certification of products and declarations of conformity, although nothing has yet been finalised.
For further information, you can read MAP’s Brexit-related news updates here.