December 4, 2019

Medical Devices Regulation: transitional provisions on the validity of certificates issued under the former Directives

On May 26, 2020, the new Medical Device Regulation 2017/745/EU (“MDR”) will enter into force. Under Article 120.2, certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC will remain valid until 27 May 2024 at the latest.

Nevertheless, there are specific conditions to extend the validity of those certificates during the interim period.

Specifically, notified bodies remain in charge of implementing appropriate surveillance measures with reference to the certified requirements. Accordingly, as stated in FAQ No. 17 of the MDR transitional provision document published by the CAMD Transition Sub Group, such controls should become part of specific contractual provisions between manufacturers and notified bodies allowing these latter to carry on such activities.

On the other hand, in order to allow manufacturers to apply Articles 120.2 and 120.3 of the MDR, the Authorities responsible for notified bodies (in Italy the Ministry of Health) must monitor their activities. To this aim, Articles 120.3 and 122.1 of the MDR provide the necessary legal basis for Member States to implement relevant national legislative measures. This interim regulatory framework will involve all notified bodies and not only those designated under the new MDR.

Therefore, after 25 May 2020, in accordance with Article 120.1 of the MDR, the NANDO Database (New Approach Notified and Designated Organization) relating to the former directives will become void while remaining available for information purposes only and the notified bodies listed therein will only be entitled to perform surveillance activities on existing certificates during the transitional period.

It is interesting to note that to date, there are only 7 notified bodies already listed in the new MDR NANDO Database while just 2 are designated under Regulation 2017/746/EU on in vitro diagnostic medical devices.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
...
Read more
Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

Close
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
Search by...
Search
Follow us on
Follow us on