Reprocessing of single use medical devices in the EU

On 28 April 2010 the European Commission published the SCENHIR’s opinion on reprocessing of medical devices, which was adopted by the SCENHIR on 15 April 2010. This opinion was commissioned pursuant to article 12a of the Medical Devices Directive, which called upon the Commission to “no later than 5 September 2010, submit a report to the European Parliament and to the Council on the issue of the reprocessing of medical devices in the Community. In the light of the findings of this report, the Commission shall submit to the European Parliament and to the Council any additional proposal it may deem appropriate in order to ensure a high level of health protection.” The Commission published its report based on the factual information contained in the SCENHIR report on 27 August 2010.

Although this information as such is not that current at this time, I wrote a an article that I have used as a basis for some other publications in legal journals that explores regulatory obligations both for the OEM as for the reprocessor, as well as product liability consequences of reprocessing, that people may find interesting.


Navigate through our knowledgebase

Related articles

Article

New sort of applicable economic operators regulation: the Market Surveillance Regulation

Attentive attendees of my presentations will have remarked in my presentations about economic operators that essential parts of the general Goods Package were being amended and that this may affect companies in…

Read more

Article

Transparency vs. Confidentiality: EFSA’s new role as from March 2021

Last month, the European Council formally adopted the new Regulation on the transparency of the EU risk assessment in the food chain, which will be applicable as of 26 March 2021. As is in the name, the new provisions aim at increased transparency of EU risk assessment, which for a large deal means strengthening the […]

Article

€ 500 per data subject – a quantification of why GDPR matters

Clients often ask me why they should invest in General Data Protection Regulation (GDPR) compliance so much. For medical devices and medicines regulatory compliance, they get it to an extent. Non-compliant devices…

Read more