On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”). This Notice applies, among others, to medical devices, active implantable medical devices and in vitro medical devices. The Q&A document provides concrete guidance on the concept of products placed on the Union market before Brexit and the transfer of Notified Bodies certificates.
The Q&A document provides that the following products will be considered to have been placed on the EU-27 market on the withdrawal date:
According to the Q&A document, proof of placing on the market before 29 March 2019 can be demonstrated by providing any relevant document ordinarily used in business transactions. This includes, for example, contract of sale concerning goods which have already been manufactured, invoice, documents concerning the shipping of goods to distribution or similar commercial documents.
In practice, such proof will be required upon importation in the EU- 27 or by market surveillance authorities. The EU-27 competent authorities must be able to verify that the documentary evidence corresponds to the individual goods and quantity presented to customs or checked by them. These documents should provide, for example, the reference to the specific identification elements of the goods.
With regard to the transfer of Notified Body certificates, the Q&A document recalls that for the purposes of placing on the EU-27 market as of the withdrawal date a certificate of an EU-27 Notified Body will be required. This means that the transfer of certificates from a UK Notified Body to an EU-27 Notified Body must take place before 29 March 2019, on the basis of contractual arrangements between the manufacturer, the UK Notified Body and the EU-27 Notified Body. In practice, it means that the new Notified Body should have issued the new certificates before Brexit.
According to Q&A document, the manufacturer of a product for which the certificate has been transferred from a UK Notified Body to an EU-27 Notified Body, must proceed to the following changes: