AMDR Response to Stakeholder Comments
The European Union is moving closer to fully implementing its requirements for single-use device (SUD) reprocessing and remanufacturing as part of the new comprehensive European Medical Device Regulation. On August 20, the European Commission (EC) wrapped up its feedback period for the proposed Common Specifications for in-house (or in-hospital) SUD reprocessing. AMDR is pleased to see and agrees with many of the comments submitted to the EC. Below is AMDR’s overview and response to the big issues based on comments submitted:
Overall, AMDR believes the stringent nature of these CS will lead most Member States to conclude that reuse of SUDs should be done only by regulated, commercial firms. Many of the proposed CS are well outside the scope of what most hospitals can or are willing to do, and thus the need for a specialized, professional industry whose sole mission is to provide safe, regulated reprocessed/remanufactured SUDs. AMDR members are diligently pursuing more and more European product offerings with Notified Bodies to obtain CE marks to respond to the challenges facing hospitals looking to reduce costs and waste and meet the new regulatory requirements.
With the release of these draft CS, AMDR urges Member States to act quickly to adopt to only allow 17.2 (or CE marked) reprocessed and remanufactured SUDs. The EU MDR gives Member States a tool to stop inappropriate hospital reuse of SUDs BUT allows for safe, professional reprocessing conducted by regulated firms, willing to assume the obligations of a manufacturer. We urge healthcare professionals looking for safe but lower cost or environmentally friendly solutions to urge their governments to act to adopt 17.2. And we urge medical device manufactures to work with commercial reprocessors to develop “reprocessable” products as a way to usher in adoption of what may be expensive medical technology, but giving hospitals a tool to reduce the “cost per use” and their overall environmental footprint.
As to the comments submitted to the Commission specifically,
AMDR agrees with a number of commentators, most notably the German Hospital Association (DKG), among others, that the draft CS goes too far in the third recital about devices “not suitable for reprocessing” (Recital (whereas) 3). We think DKG says it best, “The agreement on reprocessing of ‘single-use’ medical devices at the European level does not include any list of devices, neither of those that can nor that cannot be reprocessed. This discussion took place and the decision was made against such a list. Such a list should not be introduced through the back door by the CS, contrary to the decision of the European Commission, the Council of the European Union and the European Parliament.” AMDR’s comments are wholly consistent with this view. Dr. Christian Jaekel, an attory with a medical device law specific practice, also rebutted the third recital and perhaps said it best (pages 1 and 2), noting the limits on Commission powers as per Article 291 of the TFEU, the legislative history of the MDR, and, among other reasons, “it is not appropriate to list SUDs that are excluded from reprocessing in the CS . . .as such a listing could prospectively and inappropriately lead Member States to preclude the same SUDs from being commercially reprocessed under the obligations as a manufacturer according to Art. 172(2) of the MDR. Hospital reprocessing and regulated, commercial reprocessing is not the same.”;
AMDR also agrees with a number of commentators, including MedTech Europe, the European trade association representing the medical technology industry and the Germany Society for Sterile Supplly (DGSV) that the document needs to include a requirement that reprocessing done in accordance with these CS “be certified by a notified body,” as required in the EU MDR 17.5. This may fit best, perhaps, in Article 21;
While AMDR did not comment at length, we are in agreement with comments from DKG, Dr. Jaekel, Technical University Berlin, DGSV, MediTreat, a commercial reprocessor, and others, that the Commission’s draft goes too far when proscribing the requirements of commercial SUD reprocessors acting on behalf of hospitals. Such firms operate as manufacturers, and their regulatory requirements are already outlined in the MDR. For example, as Meditreat notes, “contractual rules are not comprised by the scope of Article 3(b) of the MDR.” And as the DKG notes, “the MDR does not provide a mandate for more far-reaching other arrangements. In this respect, only recitals 1 and 8 are relevant” and they urge striking all others;
AMDR respectfully disagrees with MedTech Europe (MTE) when they suggest informed consent and/or disclosure to patients (Recital 7 and Article 23(5)). Informed consent is a precise legal mechanism to inform patients of experimental or investigation product. Devices meeting MDR requirements or these CS are, by definition, not investigational or experimental. Altering the circumstances for which informed consent is required could have broad implications for the larger device industry. If CE marked or CS compliant reprocessed devices require informing the patient, why wouldn’t use of reprocessed reusable endoscopes, for which there is significant data demonstrating actual harm to patients? What about devices or manufacturers for which there has been a recall and instances of patient harm? This is a slippery slope;
We also respectfully disagree with MTE when they suggest Original Equipment Manufacturer (OEM) names/markings shall be removed from the devices themselves (Article 20(3)). It is hard to argue from a public health perspective, that OEM brand names should be obliterated from the handles of products; Regulatory agencies would no doubt want to know everyone that has had a hand in the life cycle of a product and the proposed CS already requires reprocessors to trace all devices. If the MDR intended to have reprocessors remove OEM labels from the devices itself, it would have said so, as it does with regard to labels. AMDR recalls this was discussed during the MDR deliberations and removing OEM brand marks from devices was intentionally NOT included in the final regulation;
Other smaller areas where AMDR is of a different opinion than MTE:
- AMDR agrees with many commentators, including DKG and Technical University Berlin, that certain Technical documentation requirements are too stringently addressed (Article 5(3)). While AMDR agrees that manufactures are under no obligation to provide technical specifications to reprocessors, MTE goes too far in its first suggested addition to this section seeking to require reprocessors to request OEMs’ rationale in supporting the single use designation.
- Repair (Article 11(G)). MTE proposes to preclude reprocessors from repairing devices. AMDR strongly wishes to protect reprocessors’ ability to employ all functions, including repair, to extend device life.
- Device marking (Article 20(1)). MTE proposes to add a requirement that devices are not just labeled as reprocessed, but individually marked on the product itself. This is unduly burdensome and sometimes infeasible on small products. Reprocessors are already required under the MDR to have traceability functions in place for all devices.
- Additional Labeling Requirement (Article 20(3)). MTE proposes to add additional labeling requirements of reprocessors indicating to consumers that the OEMs did not validate the device for reprocessing. The OEM no longer has legal title or responsibility for the SUD as the reprocessor now assumes responsibility as manufacturer of that product. This proposed addition is needlessly burdensome and not meaningful to consumers.
- Reporting of Incidents (Article 23(4)). MTE proposes to expand the Commissions’ proposal to prohibit reprocessors from reprocessing devices of an entire “type” in the event there are reported incidents. This is needlessly burdensome as no manufacturer would stop producing an entire type of product simply because there are reported incidents. In both cases, the incidents need to be evaluated rather than lead to broad-based product type exclusions.