Ensuring Compliance for Foreign Manufacturers of CE Marked ‘Legacy Devices’: Common Pitfalls and Solutions

As a regulatory representative for foreign manufacturers including those who are CE marked ‘legacy device’ in the EU, Switzerland and UK, MedEnvoy reviews technical documentation files of the manufacturers that it looks to represent in these markets.

Top five mistakes made by manufacturers of CE marked ‘Legacy Devices’ when compiling technical documentation files

During these reviews, we encounter areas in which these files do not comply with the respective regulatory requirements of these markets and provide advice to manufacturers on how they may bring their files into conformity. While there is some overlap in the types of mistakes that we see with ‘legacy devices’ and those CE marked under the MDR/IVDR, there are some mistakes unique to ‘legacy devices’ that we come across.

1. Pre-market content

We have received technical documentation files for ‘legacy devices’ for which the manufacturer has provided pre-market content demonstrating conformity exclusively with the MDR/IVDR (e.g. GSPR Checklist, MDR/IVDR classification, performance evaluation report, etc.). While preparing pre-market technical documentation files for ‘legacy devices’ to demonstrate conformity with both the MDR/IVDR and MDD/AIMDD/IVDD would not be unusual for manufacturers in the process of transitioning to the new regulatory framework, not maintaining MDD/AIMDD/IVDD pre-market technical documentation does not appropriately address the transitional provisions under the MDR/IVDR.

Specifically, under Article 120(3) of the MDR and Article 110(3) of the IVDR, ‘legacy devices’ may be placed on the market or put into service until the respective deadlines provided that they continue to comply with the applicable directive. This would include continuing to hold technical documentation that demonstrates conformity with the applicable directive. The only MDR/IVDR requirements that are applicable to ‘legacy devices’ are those relating to post-market surveillance (PMS), market surveillance, vigilance, and registration of economic operators and devices, so long as there are no significant changes in their design and intended purpose.

Therefore, foreign manufacturers of ‘legacy devices’ must ensure that they maintain and have available for their authorized representative pre-market technical documentation file content that demonstrates conformity with the MDD/AIMDD/IVDD, as applicable.

2. Post-market content and vigilance Requirements

As stated above, among the MDR/IVDR requirements applicable to ‘legacy devices’ are PMS requirements. Despite this being among the transitional provisions under the MDR/IVDR, we continue to see manufacturers that have not revised their PMS procedures for conformity with MDR/IVDR requirements, established compliant PMS Plans, or generated compliant PMS Reports / Periodic Surveillance Update Reports (PSURs) as required under the regulations. As the type of report generated by the PMS process is device risk class-based, this also means that manufacturers should have also determined the MDR/IVDR risk class for their ‘legacy devices’

As almost two years have passed since the MDR date of application, and almost one year for that of the IVDR, there is no acceptable reason to justify ‘legacy device’ manufacturers not complying with MDR/IVDR PMS requirements.

The same can be said for conformity with MDR/IVDR vigilance requirements, such as the reporting of serious incidents and field safety corrective actions (FSCAs). In the case of the Swiss and UK markets, both the MedDO/IvDO and UK Medical Device Regulations establish country-specific vigilance reporting requirements. Despite this, we continue to see manufacturers that have not updated their vigilance procedures for conformity with these requirements. 

3. Declarations of conformity

Another common mistake that we’ve observed is regarding declarations of conformity for ‘legacy devices’ that also fall within scope of other Union legislation that requires the preparation of an EU declaration of conformity.

In contrast to the MDR/IVDR, the directives do not require that declarations of conformity cover all applicable Union legislation that requires the preparation of such a declaration. Therefore, it is possible that manufacturers may hold more than one EU declaration of conformity where their ‘legacy devices’ fall within scope of other EU legislation such as:

• • Restriction of Hazardous Substances Directive 2011/65/EU (RoHS)
  • Machinery Directive 2006/42/EC
  • Radio Equipment Directive 2014/53/EU (RED)

However, we have noted on several occasions that manufacturers of ‘legacy devices’ that do fall within the scope of other EU legislation have not prepared declarations of conformity where required by such legislation. Moreso, we have observed this with devices that are certified by Notified Bodies.

As we have also noted earlier, the pre-market content of ‘legacy device’ technical documentation files must continue to demonstrate conformity with the relevant directive so there is no need for manufacturers of these devices to prepare MDR/IVDR declarations of conformity (which we have also encountered).

4. Device grouping (for IVD Systems)

As the majority of IVD manufacturers are taking advantage of the extended deadlines for ‘up-classified’ devices under the IVDR due to limited Notified Body capacity, one mistake that we have noted for IVD systems. Specifically, for those systems which depend upon reagents for result determination but also include instruments or other IVDs that fall within the scope of Class A IVDs under Rule 5, Annex XIII of the IVDR, and are placed on the market separately.

As all manufacturers should know by now, since 26 May 2022 all Class A devices must fully comply with the IVDR. In an effort to leverage the extended deadlines for ‘up-classified’ devices, we have seen manufacturers considering their IVD systems as a single ‘up-classified’ device irrespective of how the devices in the system are placed on the market. As a result, these manufacturers maintain a single IVDD technical documentation file for the entire system. This approach is inappropriate for systems where the instrument (or other Class A device) is placed separately on the market, irrespective of whether the instrument is for a single or multiple assays/tests.

In such circumstances, the technical documentation file that covers the instrument (or other Class A device) placed on the market separately, should clearly demonstrate conformity with the IVDR, regardless of whether the manufacturer has opted to maintain an integrated technical documentation for the entire system, or separate IVDD and IVDR technical documentation files covering the respective devices in the system that is placed on the market separately as either ‘legacy devices’ or devices CE marked under the IVDR.

Manufacturers of IVD systems should therefore plan the structure of their technical documentation files carefully based on a combination of both device risk classification and the manner in which devices are placed on the market.

5. Labeling/information accompanying the ‘legacy device‘

To round out the top five mistakes that we have observed in ‘legacy device’ technical documentation files, we have observed similar mistakes made with ‘legacy devices’ to those that we have observed with devices CE marked under the MDR/IVDR, including:

• • For medical devices, non-conformity with the requirements of Regulation 207/2012 covers the requirements for electronic instructions for use (e-IFUs) which continues to apply to ‘legacy devices’ until 26 May 2024 (per Article 10 of Regulation 2021/2226). In particular, manufacturers fail to have available on their websites all previous versions of the e-IFU and their date of publication, and not have prepared a documented risk assessment specific to the exclusive provision of e-IFUs. Furthermore, manufacturers should be prepared for their authorized representatives to verify the consistency of e-IFU content between versions available online and those provided as part of the technical documentation file.  NOTE: Compliance with Regulation 2021/2226) is not a requirement for IVDs. 
  • Under the Swiss MedDO / IvDO, it is not mandatory for foreign manufacturers of “legacy devices” to provide the details of their Swiss Authorized Representative on the device label or IFU, however, in such scenarios the manufacturer must still provide these details in other documentation accompanying the device. If the manner in which this information will be provided with the device is unclear in the technical documentation file, you should expect your authorized representative to reach out to you to confirm how this information will be provided as well as a sample document for verification purposes.  NOTE: Foreign manufacturers of self-certified devices must follow different rules for identifying their Swiss Authorized Representative, as compared to “legacy devices”. 
  • Additionally, Article 16 of the MedDO and Article 15 of the IvDO both establish the conditions that must be fulfilled in order to provide product information in fewer than the three official languages of Switzerland or in English. To avoid questions from your authorized representative, it is recommended that manufacturers clearly justify in their technical documentation files where product information is provided in accordance with these conditions

Consult with MedEnvoy to eliminate ‘legacy device’ technical documentation file mistakes

The above are just a few examples of the types of mistakes that we often see in ‘legacy device’ technical documentation files and for which we can also provide consulting support for a resolution.

Reach out to MedEnvoy for additional questions when preparing technical documentation files

If you have any questions regarding technical documentation file compilation, would like a gap analysis of your documentation, or require relevant training/consulting services, get in touch.