Revision of the medical device law: EUDAMED / Implantation certificate / UDI number
Health / Life Sciences
The revision of medical device legislation in the EU and Switzerland is intended to improve the quality and safety of medical devices and patient safety. This article gives you an overview of the most important changes.
The revision of medical device legislation in the EU and Switzerland is intended to improve the quality and safety of medical devices and patient safety. For clear identification, all products must be designated with a so-called UDI number (Unique Device Identification). In addition, various details must be stored in the European Database for Medical Devices (EUDAMED). Patients will now also receive an implantation certificate. However, for the time being Switzerland remains excluded from joint market surveillance with the EU, as the MRA (Mutual Recognition Agreement) has not been extended. This article gives you an overview of the most important points.
The UDI number is intended to ensure complete traceability. Manufacturers are obliged to assign a unique product identifier to each medical device and each higher level of packaging before placing it on the market. This does not apply to custom-made devices (cf. Art. 17 Para. 1 MedDO). The UDI number is product-related and must be affixed either to the labelling of the product itself or, if this is not possible, to the packaging (cf. Art. 17 para. 2 MedDO). Manufacturers must also maintain and keep available an up-to-date list of all the UDI numbers of their products (cf. Art. 17 para. 3 MedDO).
According to the EU Commission, Swissmedic will only be able to register the UDI in Switzerland once the MRA has been updated.
All medical devices shall be registered in the European databank for medical devices (EUDAMED). Certain economic operators, in particular manufacturers, importers and their authorised representatives must register within the scope of their responsibility for the products. Registration must take place before the product is placed on the market (unless registration already exists). Under the previous law, the placing on the market of medical devices was already subject to a reporting obligation (cf. Art. 6 aMedDO). In the future, the registration and updating of manufacturers, importers and authorised representatives must be carried out in EUDAMED (Art. 17 para. 5 and Art. 55 MedDO). However, until EUDAMED is fully operational, the reporting obligations under Art. 6 a MedDO remain in place.
Some of the information stored in EUDAMED must be made available to patients and the public in a comprehensible form. Art. 90 MedDO lists various information that should also be available to the public in Switzerland via EUDAMED. The personal data in EUDAMED is only stored for as long as the persons concerned need to be identifiable for market surveillance of the medical devices in question.
For implantable medical devices, the manufacturer must now - in addition to the labelling and instructions for use in accordance with Art. 16 MedDO - provide the data and information in accordance with Art. 18 para. 1 of the EU MDR*, including the implantation certificate (cf. Art. 20 MedDO). The product categories listed in Art. 18 para. 3 EU MDR are excluded from this. The list of excluded product categories may be adapted by the EU Commission by means of delegated acts (Art. 20 para. 1 MedDO).
* These include for example:
Information to identify the product e.g. product name or serial number
Warnings or precautions to be taken with regard to interactions with external agents
Information on the expected service life
The implantation certificate is issued by health care institutions that place medical implants in patients. It is a sensitive and important document for users and patients. The implantation certificate must be provided by the manufacturer in addition to the product information and is supplied with the product. Health care institutions must ensure that patients have direct access to the information concerning their implant and are able to inform themselves about it (cf. Art. 20 para. 3 MedDO). This is to ensure that the most important information, such as product name, serial number, lot number, UDI number, product model and manufacturer's name, is directly available. The implantation certificate must be provided in the three official languages German, French and Italian (cf. Art. 20 para. 2 MedDO).
Special case Switzerland
The revised Medical Devices Regulation entered into force in both the EU and Switzerland on 26 May 2021, incl. amending decree to the MedDO of 19 May 2021. But the joint surveillance (also) of the medical devices market was suspended after the extension of the MRA in May 2021 failed. With regard to this agreement, Switzerland is currently considered a so-called MDR (Medical Devices Regulation) third country and no longer benefits from the uniform market surveillance together with the EU states.
For this reason, the authorities and citizens in Switzerland will not have access to EUDAMED until further notice. In addition, the registration of medical devices in Switzerland will continue to take place via UDI number, and Swiss economic operators will continue to register with Swissmedic. This development means that the Swiss medical technology industry will lose its previously barrier-free access to the EU internal market.
According to estimates by the industry association "Swiss MedTech", the administrative effort required to meet the third-country requirements costs the Swiss medical technology industry CHF 114 million at the beginning and CHF 75 million annually thereafter. These costs correspond to 2 percent or 1.4 percent of the export volume (CHF 5.2 billion) from Switzerland to the EU. The increasing administrative costs due to the "third-country paperwork" are accompanied by a loss of location and investment attractiveness in international competition.
Conclusion: Significant additional costs for all players and ultimately a weakening of care and patient safety in Switzerland.
Our team specialising in health law is happy to assist you in all legal matters relating to medical devices. See also our magazine articleregarding the increase in obligations to act for manufacturers of medical devices as well as the update on the urgently needed update of the Mutual Recognition Agreement (MRA) with the EU. In our "MME Magazine" you will regularly find further articles on this topic.