ENVI’s amendments, following those of IMCO  have been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 – 907 on medical devices and 75 – 399 on IVDs), but here is a list of the things that I found particularly interesting. I am sure other people would  put other accents in this huge pile of amendments, so I would encourage you to read them for yourself for a full  and unbiased picture.

Mind you, these amendments are additional to the reports that the rapporteurs Roth-Behrend and Liese produced earlier so they will not repeat those proposals in there. Also, the amendments are not always consistent with each other: there may be multiple amendments for the same clause by different people. Overlay these with the IMCO ones (88- 212 on medical devices) and the first outlines of political compromise will start to show; the rest will remain subject of debate.

This post does not include the IVD amendments yet, I’ll discuss these in a later post.

Medical devices amendments

So, here we go for the list of items in the amendments that I think should be flagged:

• No more updating of Annex II (essential requirements) and contents of Annex III (format of declaration of conformity) by means of delegated act
• Analysis and reporting of PMS by “independent organizations” (no guidance on what those might be)
• PMSP (post market surveillance plan) to be validated by authorities responsible for granting or re-evaluating market authorizations, and be carried out by an independent authority which has in no way contributed to the device’s market authorisation or the re-evaluation thereof (that will be interesting, authorities carrying out post market surveillance plans of manufacturers – seems highly unpractical)
• Increased information obligations by manufacturers to parties other than authorities (consumer associations, for example)
• Responsibility for the placing on the market of products on the part of the authorized representative (this solves an old problem  of unclear drafting in the different language versions of the current directive, but will change the game of ARs substantially)
• Mandatory product liability insurance for manufacturers, plus an obligation to bear costs to the health system to treat patients harmed as a result of malfunctioning or defect devices, as a condition for importation into the EU of devices (I’m not sure if this will fix the problems that it intends to fix, because insurance companies are not in the business of paying out claims and this may backfire on the patients if there is not more detail on the timelines for settling claims etc.)
• A surprising softening of supply chain responsibilities for distributors (e.g. no obligation to do recalls, which I find unbelievable and contrary to the MAID system as set up horizontally)
• Some tweaking of the QP’s qualification requirements
• Reuse of a device outside of the specifications set out in the manufacturer’s instructions for use makes a person or company manufacturer (this makes a lot of sense, because such reuse takes a device outside the scope of its CE mark)
• Various amendments pushing and shoving on reprocessing (whether or not the reprocessor is manfacturer or just needs a quality system), placeholders for delegated/implementing acts on requirements and mechanisms for determining maximum number of reprocessing cycles and devices that cannot be reprocessed at all, information obligations to patients about whether a device has been reprocessed (as I have blogged, the reprocessing regime proposed is nuts and will backfire on the market and the patients – it will upset liability and risk for manufacturers and basically oblige manufacturers to do the reprocessor’s clinical validation. The reprocessor, in turn, will have no incentive to innovate in materials or devices that can be reprocessed better – everyone loses.)
• Electronic version of the implant card
• Compatibility requirements for modular implants with a view to replacement of parts
• Reversal of burden of proof of product liability (“The manufacturer will be held as legally responsible for the damage caused by a class IIb or class III medical device to the patient, unless he can prove the damage was caused by improper application by the healthcare professional or the patient, where relevant.”) (this is an exception to the burden of proof in directive 85/374, which provides for a burden of proof on the patient. If this is adopted, medical devices will be the only sector with a diverging burden of proof (not even medicinal products have that), which does not make sense. Better amend the Product Liability Directive, but that will be politically too complex. Therefore, legally speaking this amendment is pure window dressing and does not stand a chance.)
• Compatibilty of traceability systems (good idea, but how about some standards?)
• Language harmonization in registration (IMCO’s idea too (stolen from the Dutch), the more the better)
• Single registration procedure (already applies for IVDs)
• Various additional requirements for reporting on safety and clinical performance
• Various amendments on the level of access to Eudamed of clinical professionals and the public
• Primate of responsibilities for notified bodies explicitly with the accrediting member state (goes against what IMCO proposed with a supranational system, except for an amendment that reserves this for NoBos claiming devices listed in class III, those implanted into the body, incorporating a substance considered to be a medicinal product, or utilising non- viable tissues or cells of human or animal origin, or their derivatives)
• Various amendments on formalities surrounding conformity assessment (duration etc)
• Member states may impose minimum frequency of unannounced inspections; taking away of competence of the European Commission in that respect by delegated act (Bad idea, member states have already demonstrated enough that they can’t be trusted with market surveillance)
• Deletion of Commission competence to supplement conformity assessment procedures by delegated act (hate it or love it, but we will go back to complete overhauls of the whole statute for small changes, and the past has demonstrated that this is not the best solution)
• “At all of the stages in the conformity assessment procedure, the notified assessment body shall carry out at least one unannounced inspection at the manufacturer’s production facilities before making a decision on conformity.” (this is nuts, doing unannounced inspections on production facilities before (SIC) production has started or the facilities would be required to even be present)
• Proposals for PMA alternatively scrutiny for various types of devices (this is the big wild card)
• Proposal for scrutiny of notified bodies and peer review of competent authorities responsible for notified bodies
• Unannounced inspections at least once a year during the duration of the certificate of a device (but other proposal to credit the cost, nature and extent against regular inspections)
• More detail on clinical investigation and a push to re-involve Ethics Committees (in alignment with the revision of the Clinical Trials Directive, so no surprise)
• Many amendments on the varying levels of access to clinical trials section of Eudamed  for healthcare professionals and the general public (interesting in the light of the pending Intermune case at the European Court)

• Proposal for medical devices PSURs
• Hierarchy provision for blood and blood components rules (higher than medical devices rules)
• Competence for (cross-border) (joint) inspections by member states at operator premises
• Obligation for member states to draw up strategic monitoring plans for surveillance, on which the Commission may give recommendations (interesting idea)
• Setting up of a Medical Devices Advisory Group to advise the Commission  and the MDCG on the technical, scientific, social and economic aspects of the placing on the market and availability of medical technology and related services in the Union, comprised of representatives from associations of patients, clinicians, nurses, carers and healthcare facility managers, relevant medical device manufactures and other relevant fora.
• Several amendments around the competences of the MDCG and especially what it can do in terms of policy setting and development of guidelines
• Amendments on the design requirements in relation to dangerous substances and nano materials (very prescriptive, better to leave that to be filled in on state of the art basis with CTS for example)
• Labeling amendments to make the distinction between medicinal products and medical devices ‘clearer’ (window dressing coming from old age thinking that medical devices are nuts and bolts products)
• Amendments on the requirements for notified bodies annex to raise the bar and implement parts of the Notified Bodies Code into the regulation, including on unannounced inspections (which may explain why the Commission is waiting with its Recommendation on unannounced inspections that was supposed to become public and enter into force this month)
• Amendments to conformity assessment routes for various scary and risky devices
• Clinical criteria for implantable and class III devices: novel devices must do more than demonstrate equivalence, iterations may do so
• Clinical investigation requirements for incapacited persons and minors

First impression

Some good, some bad, some crazy – that sums it up about the amendments in my opinion. A lot of the amendments concern wordsmithing (changing political drafting qualifiers like “appropriate cases” to “without exception” etc). As the IMCO amendments, the video report of the 6 May ENVI meeting and these amendments show, the animo for PMA is actually not that high and the rapporteur seems to have limited political support for this option. The Commission does not see any benefit in it (just watch the video report and see Mrs Spanou, the Director for Consumer Policy at the Commission, grit her teeth trying to stay polite) and the Member States are in no mood to take on this task or give part of it to the EMA. I am happy to see this, because as I have argued repeatedly and as even the EMA has already stated: more pre-market control does not make for better protection of the public if the products are already safe enough. Post-market controls do and that is the way to go forward. I am happy to see that this message is not wasted on many of the other parliamentarians as many of the amendments have picked up this point. I hope the same happens with the reversal of regulatory logic on reprocessing that will also lead us nowhere, will make treatments with devices potentially a lot less safe and will not solve the cost issues (remember, Roth-Behrendt says ‘single use labeling is printing your own money’ – like facilitating a whole industry based on reprocessing of devices that are not intended to be reprocessed is not printing money, while on top of that risking patient safety and jeopardizing outcomes in the bargain). What I am still sorely missing is an obligation on HCPs to report incidents – they are the first to notice that something is wrong with a device so they should be under an obligation to report incidents (and not sweep it under the rug as a complication if they are afraid that further investigation shows that it was a user error and not a device failure).

And then

The ENVI committee, the lead committee in this dossier, will deliberate about its own amendments and those of the IMCO committee. It will subsequently vote what amendments will be put to the vote in Parliament’s plenary meeting (see my last post on IMCO’s amendments). And then the Council will need to put the cards on the table that it so far has been keeping tightly against its chest.