The approval of the new European (EU) Medical Device Directive (MDR) and EU In Vitro Diagnostic Regulation (IVDR) on April 5, 2017 by the EU Parliament in Strasburg, France has prompted the implementation phase of this new and significant legislation. Its legal debut entitled, “Entry into Force,” follows 20 days after publication in the European Official Journal (EUOJ).
While the ink is still wet, the debates are in full swing to understand the impact and consequences of the all-important transition definitions and expiration dates of existing and extended MDD/AIMD Certificates as defined in Article 120.
And indeed, if one compares the consolidated MDR legislative text (February 2017) with the draft MDR text (May 2016), there are important and noteworthy changes. Industry pressed hard and succeeded on securing additional transition time to keep MDD/AIMD certificates valid for so-called legacy products – medical devices that are already in commercial distribution and designed and manufactured under current MDD/AIMD requirements – with adjusted timelines that go well beyond the three (3) year transition period.
Following the official publication of the EU MDR, expected in May/June 2017, medical device manufacturers will have three (3) years, plus 20 days, to become fully compliant. Does this mean no more legacy devices beyond the Date of Application (DoA)? The simple answer is “no,” as inherent in any complex legislation are exemptions to extend transition timelines.
MDR Article 120 creates exemptions for medical devices with a valid MDD/AIMD CE-Mark certificate that expire after the DoA. Two (2) important scenarios need to be considered under this circumstance:
Continued Distribution of currently manufactured devices:
CE-Marked legacy devices have a maximum of five (5) more years to transition, assuming they are manufactured, packaged, labeled and released into a finished goods warehouse before the transition end date of June 2020 (DoA). This assumes a valid MDD/AIMD certificate that expires post-release into finished goods.
These medical products can be placed on the market and commercially distributed for up to five (5) additional years starting with the DoA. This is consistent with other transition rules under the old MDD/AIMD. For example, an MDD/AIMD certificate may be expired, but it is still required so the certificate on the declaration of conformity may be referenced to prove compliance of legal manufacturing conditions.
However, with the commercial distribution of these legacy devices comes new post-market regulatory requirements. Many new and different surveillance requirements will likely be applicable and may be implemented with the new EN ISO 13485:2016 Quality Management System standard. This standard will be mandatory beginning June 2019 and will replace its predecessor, ISO and EN ISO revision(s).
Continued Manufacturing, distribution and placing on the market:
But, there’s even more to consider. MDR Article 120 provides yet another exemption. The second paragraph in Section 2 will allow medical device manufacturers to continue their commercial manufacturing (and distribution) of approved medical devices under the scope of valid MDD/AIMD CE certificates for a period up to four (4) years beyond the DoA.
However, the commercial manufacturing and distribution of legacy devices is not without risk and undue burden. The most challenging will be: 1) to continually meet state-of-the-art safety and performance requirements; and 2) to avoid any significant changes to the approved design properties and manufacturing methods, including labeling and packaging, as well as warehousing and storage conditions that would require a change notification to the respective Notified Body (NB).
In addition, manufacturers will need to apply all new MDR post-market PMS, PMCF and registration requirements, including economic operators (and potentially UDI requirements), and still follow all other pre-market requirements in accordance with the old MDD.
The below infographic summarizes these important transition timelines for the above scenarios including the two (2) year extension for legacy devices under a valid MDD Annex IV Certificate.
(Click here to see the full infographic.)
There are considerable restrictions in continuing to manufacture legacy medical devices for commercial distribution beyond the DoA under the old regulatory framework. For example, a medical device must meet all applicable essential requirements for safety and performance as specified and agreed upon with the MDD/IAMD certificate-issuing NB. However, this only applies to products under an MDD/AIMD certificate – no Class I product exemptions! The issuing NB will now be able to re-issue or revise the MDD/AIMD certificate, but not changes in the legal manufacturer status, manufacturing address, listed subcontractors, etc.
NBs will need to stay in business long enough to supervise the MDD/AIMD certificate process during the extension period and perform surveillance assessments. That is bad news for legal manufacturers that have selected NBs that are expected to go out of business.
Any of the above requirements might create a sudden and unexpected stop to the extended transition timeline for a legacy device. However, even in these cases, legacy products that are released into the warehouse with appropriate QMS documentation and a valid Declaration of Conformity can be placed on the market until the end of the five (5) year sell-off stock period (until 2025).
Additionally, legacy medical devices can still be manufactured and placed on the market at risk within (4) years from the DoA. This manufacturing timeline extension may be best utilized to replenish residual warehouse stock related to forecasted supply and demand, and to avoid distribution bottlenecks.
However, with the MDR’s new perspective on continuous improvement, including increased and periodic post-market surveillance and reporting requirements on clinical safety and performance, it is assumed that regulatory compliance for legacy medical devices will be closely monitored and challenged.
In conclusion, the new MDR will be challenging and present considerable business risks for medical device organizations as they continue to manufacture and distribute legacy medical products beyond the DoA.
With restricted modification options to improve – or to maintain – safety and performance characteristics of legacy devices, it remains to be seen if the current transition process in Article 120 will stand. Either way, manufacturers should not confuse the exemptions in Article 120 with appropriate and timely transition management.
A medical device manufacturer’s regulatory business strategy should focus on optimizing medical product portfolios and a plan for a timely MDR transition if they are to be successful long-term.
NAMSA’s global regulatory experts welcome the opportunity to discuss strategic options related to the new MDR regulations, including potential business impacts – and more importantly – how your organization can plan for success.