Marcin Rytel
EU law on medical devices: New transition periods and other changes
Amendments to the EU’s provisions on medical devices were published in the Official Journal on 9 July 2024. The new rules will begin to apply six months after publication (i.e. from 10 January 2025). In vitro diagnostic devices are gaining extended certificate validity and longer transition periods. The EUDAMED database can be launched in steps, which should speed up the mandatory use of the modules that are now ready. Meanwhile, manufacturers and other participants in the distribution chain have a new obligation to report problems with availability of medical devices.
Uncork the QR codes!
Food manufacturers are eager to use QR codes on their labels. Now the EU has normalised the use of these codes in the regulations. For now, the new rules apply only to the wine industry, which is pioneering in this area of food labelling. The QR code rules should make it easier for the industry to meet its new obligations to provide wine consumers with ingredients and nutrition information.
Will pharmacy M&A still be possible?
On 17 August 2023 the parliament held its final vote on a bill to tighten the section of the Pharmaceutical Law known as “Pharmacies for Pharmacists.” Now the act will be sent to the President of Poland, who will decide whether to sign it into law. The amendment (known as “Pharmacies for Pharmacists 2.0”) is stirring a lot of controversy. Its entry into force would significantly restrict the possibility to buy and sell pharmacies, and would require the Pharmaceutical Inspectorate to scrutinise franchise agreements. Pharmacy chains are concerned that the new provisions will lead to expropriation.
Advertising of medical devices: Currently only with warnings
On 13 May 2023, a new regulation with detailed requirements for advertising of medical devices enters into force. Advertisers of such products, including influencers, must include warnings in advertising messages, similar to those familiar from drug advertisements.
Extending the validity of medical device certificates (March 2023)
On 20 March 2023, an amendment to the Medical Device Regulation was published in the Official Journal of the European Union, extending the validity of certificates for medical devices issued under the earlier regulations. The amendment was adopted as a matter of urgency and went into effect immediately (on the date of publication). The extension is intended to prevent shortages of medical devices on the market.
