Many changes are occurring on the European continent concerning transport, import and distribution. The main reasons are the consequences of Brexit and the new Medical Device Regulation, that will become fully applicable on 26th of May 2021. Being an European Authorized Representative, we are often asked about the main responsibilities and obligations of the manufacturers and Economic Operators.
Import from Great Britain to Ireland
One of the substantial changes is concerning the way medical devices are imported from Great Britain to Ireland. The main responsibilities of the manufacturer/exporter/importer of the medical device are:
- To have oversight of the supply chain;
- To understand the new requirements applicable to product being imported from GB or being transported via the UK land bridge under the customs transit procedure;
- To liaise with logistics companies and to be satisfied with the appropriate arrangements in place to manage the new customs requirements;
- To have access to all necessary travel documents/numbers such as the pre-boarding notification (PBN) ID and/or Master Reference Number(s) (MRNs), so that any issue impacting on the supply of medical devices is resolved as soon as possible.
Placing goods in Switzerland
Another issue that will rise in the following months concerns the placing on the market of medical devices in Switzerland – and the other way around, placing goods coming from Swiss manufacturer on the EU market. When it comes to the latter, if no Mutual Recognition Agreement (MRA) is signed/reached by May 26, Switzerland will obtain ‘’a third country’’ status and those devices that Swiss manufacturers want to place on the EU market will have to meet third country requirements. For a recap of these changes, click on one of our previous articles.
On the other hand, manufacturers that want to place their goods in Switzerland, will have to meet the requirements of the new Swiss Medical Ordinance, MedDO. For example, non-Swiss based manufacturers will have to appoint a Swiss Authorized Representative. Facing a potential supply shortage, Swiss MedTech has already issued several guides to help manufacturers to both import and export from Switzerland.
Junior Consultant, Publishing department
Are you interested in placing your devices on the Irish market? Are you placing your goods in Switzerland? Obelis will gladly help you understand the novelties, safeguard your compliance and inform you of all the regulatory changes that effect your business. Contact us today and assure your compliance before May!
- HPRA. (2021). Brexit — Importing medicines and medical devices into Ireland from Great Britain. Retrieved on 19/03/202, from https://www.hpra.ie/homepage/medicines/news-events/item?t=/brexit-importing-medicines-and-medical-devices-into-ireland-from-great-britain&id=e0c60e26-9782-6eee-9b55-ff00008c97d0
- Swiss MedTech. (2021). Open Letter – Preventing a supply shortage of medical devices. Retrieved on 19/03/2021, from https://www.swiss-medtech.ch/en
- Official Journal of the European Union. (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Retrieved on 19/03/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745