Corrigendum to the Medical Devices Regulation – On 25 November, the European Council presented a corrigendum to Regulation 2017/745 on medical devices in Brussels. This publication consists of a correction or errata list which has identified up to 10 citation errors in the original text of the Regulation and amends Article 120(3) concerning low-risk medical devices (Class I).
Image: Cover page of the publication of the Corrigendum to Regulation (EU) 2017/745 of the European Council on Medical Devices.
What are the main changes introduced by the Corrigendum?
The Corrigendum submitted last November it does not substantially affect the current text in technical matters. The aim is not to correct conceptual errors regarding the regulations, nor to amend the technical content of any of its sections, but rather to rectify certain errors in summonses as set out in the original document.
The publication of a new European health regulation It’s always a matter of one great complexity. And that is because they involve a large number of professionals and consultants with technical expertise – and, in many cases, political figures and lobby groups as well – who face the challenge of reaching a consensus on positions that take account of all the sensitivities of the member countries.
There’s no denying it: sometimes the need for immediacy and the constant changes in the sector mean that, even in the EU’s own legal texts, it is common to find minor errors in the citations. On this occasion, the Corrigendum to the Medical Devices Regulation 2017/745 It has corrected 10 errors in the original publication, which affected all the European languages in which the Regulation has been published.
Just for interest’s sake, here are two of the typographical errors found in the original text of the new Medical Devices Regulation:
Article 120(3): low-risk medical devices (Class I)
Although a corrigendum is usually used to make minor corrections to legal texts, in this case a change has been introduced that does have a significant impact on the legislation governing medical devices. This is the amendment to Article 120(3), which affects low-risk PSs (Class I). From now on, according to the Corrigendum, these products must be reclassified into other, higher-risk categories.
Furthermore, as the association has explained Anefp, in a statement issued by Maite López Gil, «this measure ensures that these products may remain on the market until 26 May 2024». In other words, in practice, these products may remain on the market for a further four years, provided they have a declaration of conformity drawn up before 26 May 2020.
What else do you need to know about the new Medical Devices Regulation?
At GTF, we specialise in the regulation of Medical devices. We can provide technical advice on your project to help you interpret the new European legislation correctly. We have a whole range of range of services on medical device regulation, designed to ensure your company is ready for the day when compliance becomes mandatory. Still not sure when that will be? We make it easy for you. Check the meter on your right.