Nov 01, 2022
25 EU MDR Articles That Apply to Legacy MDD Medical Devices Right NOW
Does this situation sound familiar? You’re sitting on an existing valid Medical Devices Directive (MDD) certificate that expires sometime before May 26, 2024. You assume that any obligations to meet the requirements under the Medical Device Regulation (MDR 2017/745) don’t apply until you get CE certification for that device under the MDR.
Are you correct? Well, not so much, and you’re definitely not alone.
Even the manufacturers that did understand there were some obligations to be followed after the compliance date of May 26, 2021, were certainly confused about what they were supposed to do. In response, the Medical Device Coordination Group (MDCG) released MDCG 2021-25 guidance in late 2021. Before we outline what needs to be done, it’s important to understand the distinction made between old and legacy devices.
- “Old” devices have valid MDD or AIMDD certificates and were placed on the European market before May 26, 2021, the date of application of the MDR.
- “Legacy” devices have valid certificates but were placed on the European market after May 26, 2021. The definition of legacy devices may be a little confusing because it would seem that any device placed on the European market after May 26, 2021, would be subject to the requirements of the MDR, but for these devices, the MDD CE certificate was obtained before this date and remains valid until expiration or May 26, 2024, whichever comes first. This also applies to a lot of Class I reusable surgical devices and some software, which are being “upclassed” and don’t need to comply until 2024.
There are numerous articles (sections) within the MDR, many of which you are likely already following as part of your ongoing compliance with the old MDD.
Postmarket Surveillance (PMS) and Vigilance
Theoretically, this is where the distinction between old and legacy devices becomes important. MDCG 2021-25 specifies that the requirements of Chapter 7 of the MDR (see relevant articles below) only apply to legacy devices. In practice, we are seeing that Notified Bodies are expecting this for all devices, regardless of the distinction between legacy and old. Easy access to all MDR articles listed below can be found here.
- Article 83 – Post-market surveillance system of the manufacturer
- Article 84 – Post-market surveillance plan
- Article 85 – Post-market surveillance report
- Article 86 – Periodic safety update report
- Article 87 – Reporting of serious incidents and field safety corrective actions
- Article 88 – Trend reporting
- Article 89 – Analysis of serious incidents and field safety corrective actions
- Article 90 – Analysis of vigilance data
- Article 91 – Implementing acts
- Article 92 – Electronic system on vigilance and on post-market surveillance
- Article 93 – Market surveillance activities (also applies to “old” devices)
- Article 94 – Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
- Article 95 – Procedure for dealing with devices presenting an unacceptable risk to health and safety
Economic Operators (EO)
All manufacturers located outside of the European Union already have a European authorized representative (EC REP). However, many manufacturers do not realize that Article 13 of the MDR added a new role called an “importer.” This terminology is rather confusing because the importer is not responsible for customs clearance or warehousing activities that you might associate with the term. Instead, this “economic operator” role focuses on regulatory compliance and has similar responsibilities to your authorized representative.
- Article 11 – Authorised representative (point 3, subpoints C-G; also point 7)
- Article 13 – General obligations of importers (points 2, 4, 6, 7, 8, and 10)
- Article 14 – General obligations of distributors
EUDAMED is the new medical device database used by European Competent Authorities and is also available to the public. It is being rolled out in phases and is therefore not yet fully operational. Still, many provisions apply.
- Article 22 – Systems and procedure packs (only applies to system or procedure packs combining legacy and MDR devices)
- Article 29 – Registration of devices (only certain provisions apply until EUDAMED is fully functional)
- Article 31 – Registration of manufacturers, authorised representatives and importers (only certain provisions apply until EUDAMED is fully functional)
- Article 100 – Electronic system on market surveillance (applies to “old” devices as well)
- Article 10 – General obligations of manufacturers (points 10, 12, 13, 14, and 15)
- Article 96 – Procedure for evaluating national measures at Union level
- Article 97 – Other non-compliance
- Article 98 – Preventive health protection measures
- Article 99 – Good administrative practice
Making Sure You Remain MDD and MDR Compliant
Maximizing the ability of your existing MDD CE certificate is no doubt important, and thus, it’s vital that you meet the MDR postmarket surveillance and other requirements applicable to legacy devices. Our team is ready to help ensure a smooth transition to the MDR for legacy (and new) devices. We offer MDR training, transition support, gap assessments, and more.