Why Manufacturers of Legacy (MDD) Medical Devices Need to Comply with Parts of the EU MDR

Although the European Medical Device Regulation (MDR 2017/745) took effect in May 2021, a significant percentage of manufacturers still hold valid CE certificates that comply with the Medical Devices Directive (MDD 93/42/EEC). Those devices can continue to be placed on the European market until their certificate expires or May 26, 2024, whichever comes first.
 
While the transition period buys time for manufacturers not ready to get those MDD devices certified to the MDR, many are blissfully unaware that they still need to comply with certain aspects of the MDR.
 
It’s an oversight that might come back to bite them. Why the lack of awareness? Buried in Article 120(3) of the MDR was some language of which most manufacturers understandably might have overlooked or misunderstood.
 
Article 120(3): “By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024 provided that from, 26 May 2020 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.”
 
So why did the regulators add this language? The reason was to avoid creating a parallel supply chain universe between now and May 2024 (the grace period). The situation they are trying to avoid is having some devices that are MDR compliant, while others are legacy MDD devices, yet nobody can discern by their label which ones are subject to distributor (Article 14) and importer verification (Article 13) required under the MDR.  

Not All Legacy Devices are Created Equal

Still the first sentence in Article 120(3) did create some confusion because it was poorly written and some would interpret it as only applying to Class I sterile and measuring devices. The MDR did not clearly define so-called “legacy” devices but MDCG 2021-25 (PDF released in October 2021) did and places them into two distinct buckets:
 

• Legacy devices – Class I sterile, Class I measuring, Class IIa, IIb, III or active implantable medical devices holding valid CE certificates that were placed on the European market AFTER May 26, 2021. The MDR provisions apply.
• Old devices – Medical devices holding valid MDD or AIMDD certificates that were placed on the European market BEFORE May 26, 2021. MDR provisions do not apply because they are already on the market.

Implications for a Manufacturer’s QMS

Of course, many manufacturers have more than one device family in their portfolio. Some devices might be MDR certified, while others may only hold unexpired MDD CE certificates. This issue here is that the manufacturer would need to operate parallel quality systems to accommodate legacy MDD and MDR products for the duration the legacy devices are on the Union market.

Compliance with EU MDR Requirements for Surveillance

Lest you still have doubts about Post Market Surveillance (PMS) provisions applying to legacy devices, let this statement from MDCG 2021-25 put any doubt to rest: “In accordance with MDR Article 120(3), 1st subparagraph, all relevant requirements set out in Chapter VII of the MDR on post-market surveillance, market surveillance and vigilance apply to ‘legacy devices.” We won’t go into the weeds about the PMS requirements applicable to legacy MDD devices other than to say that you should carefully study Chapter VII of the MDR and pages 5-8 of MDCG 2021-25.

The MDR Article that Catches Most Manufacturers Flat Footed

Aside from the need to comply with the post-market surveillance and vigilance requirements of the MDR, perhaps the issue that catches most companies by surprise is MDR Article 13. This Article elevates the role of Importer as a key Economic Operator and requires all manufacturers (even those currently selling legacy devices) to specify an importer. The term “importer” is confusing because it sounds as if role is associated with logistics and product handling. It does not have to be to act or to become the importer. The importer as defined in the MDR can be an entity that is taking responsibility for meeting its obligations without a need to take title and/or physical possession of the devices it represents and merely takes on a compliance role similar as defined in Art 13 of the MDR and where some of the obligations overlap with the obligations of the European Authorized Representative and Distributor. 
 
Some of the MDR language in Article 13 is written assuming that the manufacturer will act as their own importer. While that may be true for many EU-based manufacturers, many non-EU medical device manufacturers do not have legal entity registered in an EU country. As such a third-party EU importer is required and recommended. The importer must be identified on labeling or in an insert that rides along with the device and has financial liability for your devices placed on the EU market.

Be Careful About Making Changes to Your Device

Manufacturers maximizing their existing MDD certificates do need to be careful about making changes to their devices so they do not trigger required certification to the MDR. Again, back to Article 120(3) of the MDR which includes language that says “…provided there are no significant changes in the design and intended purpose.” What counts as “significant”? Well, of course, there’s a guidance document for that too.
 

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Rene van de Zande is a partner and commercial director of MedEnvoy Global BV, a medical device and IVD importer and regulatory compliance firm based in The Netherlands. Rene was formerly CEO of a major medical device regulatory compliance firm and has more than 30 years of experience in field. He can be reached at [email protected].
 
Daryl Wisdahl is the director of QA/RA for MedEnvoy Global BV.  Daryl has more than 25 years of experience in the medical device industry and has been specialized in Quality Management System (QMS) implementation and compliance, and regulatory submissions for medical devices.  He can be reached at [email protected].