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Focus on Regulation

Poland: official position of the competent authority on consequences for medical devices in the event of a no-deal brexit

On 1 March 2019[1], the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the medical devices.

It is announced that in the event of a “no-deal” Brexit, as from 30 March 2019, the United Kingdom will be considered a third country. In this case the following consequences will affect:

  1. notified bodies and conformity certificates from the UK

Notified bodies (BSI Assurance UK Ltd, Lloyd’s Register Quality Assurance Ltd, SGS United Kingdom Ltd, and UL International UK Ltd) will lose their notification. As a consequence, the certificates of conformity issued by these bodies will no longer be valid.

The exception is when another notified body assumes direct responsibility for the devices and undertakes to re-certify these products within 12 months. The certificates will then remain valid for this period. The validity of the certificate can only be stated with the written confirmation from the new notified body. However, the Office emphasizes that this is a national regulation and these certificates might not be recognized in other EU member states.

  1. manufacturers from the UK

Any manufacturer residing or established in the United Kingdom will be required to appoint an authorised representative. The name and address of this representative must be stated on the label or in the instructions for use. If the manufacturer is from a third country and its former authorised representative resides, or has its registered seat, in the UK, it must appoint a new representative with its seat or residence in the Member State.

Moreover, neither manufacturers nor authorised representatives, either resident or established in the UK, will now be allowed to sponsor clinical trials of medical devices.

  1. distributors from the UK

In the cases referred to above, the distributors will be obliged to notify the President of the Office of any changes concerning the authorised representative of a medical device which manufacturer or authorised representative is either resident or established in the UK.

In addition, distributors importing medical devices from the UK will now become importers. They will not be required to re-notify the President of the Office about imported devices if they have already done this before 30 March. However, they will still be obliged to notify the President of the Office of any aforementioned change concerning the manufacturer or representative.

The consequences of Brexit described above will not apply to medical devices which, before 30 March 2019, were legally marketed in a Member State other than the UK. These devices can continue to be marketed and put into service in Poland.

The new communique provides further information in relation to the impact of Brexit on the Life Sciences & Healthcare industry in Poland after the release of the communique concerning necessary post-registration changes in medicinal product documentation of 25 February 2019 and the Polish Minister of Health’s statement on the effects of Brexit on reimbursement of 6 December 2018.

 

[1]              The communique in Polish can be found on the official website of the office: Brexit-related communique concerning medical devices