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:
- Products physically in the distribution chain or already in use in the EU-27 market on the withdrawal date. For example: an X-ray machine certified by a UK Notified Body held in the EU-27 by a wholesaler or already supplied to a hospital in the EU-27, where it is in use. These products will be considered as placed on the EU-27 market before 29 March 2019. This means that the manufacturer will, therefore, not be required to re-certify and re-label the device.
- Products manufactured either in the EU or in a third country, sold to an EU-27 customer before the withdrawal date after the manufacturing stage was completed but not yet physically delivered to the EU-27 customer on that date. For example: an X-ray machine manufactured in the US and certified by a UK Notified Body sold to a Dutch hospital on 15 March 2019 but which will only arrive at the Dutch customs on 5 April 2019. The date of the transaction between the manufacturer and the EU-27 customer (15 March 2019) will be considered as the date of placing on the market. The Q&A document provides that placing on the market does not require physical delivery of the product.
- Products imported into the UK from a third country or manufactured in the UK, subsequently sold to an EU-27 customer before the withdrawal date but the physically delivered to the EU-27 customer as of that date. For example: an X-ray machine manufactured in the UK and certified by a UK Notified Body sold on 25 March 2019 either directly to the Dutch hospital or by UK distributor, and arrived at Dutch customs on 5 April 2019. Similarly to the second scenario, the date of placing on the EU-27 market will be the date of the transaction.
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:
- For products placed on the EU-27 market after the withdrawal date, both the EU Declaration of Conformity and the Notified Body Certificate will have to be updated. The certificate will have to mention that the product is under the responsibility of an EU-27 Notified Body and indicate both the old UK and the new EU-27 Notified Body’s details/identification numbers.
- For products already placed on EU-27 market or for products manufactured before the transfer of certificate has taken place (and not yet placed on the EU-27 market), there is no need to change the Notified Body number on the products if the above-mentioned product documentation is in order. However, products manufactured after the transfer of certificate has taken place should be marked with the new EU-27 Notified Body number. It will, therefore, not be possible to continue to use the UK Notified Body number until the end of the validity of the original certificate issued by it.
Please contact our team if you have any questions regarding Brexit and the implications for medical devices.