ODEP and Beyond Compliance: Our response to Cumberlege, the MDR and the UKCA... making UK plc a good place for safe innovation of implants

Keith Tucker and Peter Kay

After about nine month’s delay, Baroness Julia Cumberlege’s long awaited ‘Independent Medicines and Medical Devices Safety Review’, “First Do No Harm” was published on 4th July 2020.

It must be the view of the great majority of us that what she recommends makes perfect sense. As far as orthopaedics is concerned, it will impact on us (provided parliament adopt her recommendations) in several ways:

• All implants used on patients will have to go into a registry and ‘Scan for Safety’ is highlighted and plans are already afoot for its development. • The monitoring of new devices should not be left to the PI (Principal Investigator), their team and the manufacturer. An independent body should be involved which is, of course, what the Beyond Compliance advisory group have been doing for some years now. • Anyone involved in the introduction of new devices should increase their emphasis on PROMS and PREMS. • We all need to increase our engagement with patients and the lay public when dealing with implants. • She emphasised the importance of anyone externally monitoring implants should be completely independent and without a conflict of interest (COI). That’s pretty easy for ODEP and Beyond Compliance as none of us are paid!

So where is ODEP and Beyond Compliance in this?

Well, she mentioned the NJR as a beacon organisation that others should follow and I am sure we all agree it certainly is! We think it was unfortunate that ODEP and BC were not introduced to her but what we have been doing since 2002 for ODEP and 2012 for Beyond Compliance fits very closely with her recommendations.

Where are we all with the new MDR?

Oliver Bisazza from MedTech Europe has summarised the introduction of the new MDR very well in Figure 1.

However, earlier this year, because of COVID-19, the next time point in the implementation stage was put back until May 2021. The important points to realise are:

• Manufacturers will not be able to introduce a novel device without a pre-clinical investigation. • We expect only a few devices will get a CE mark on the basis of ‘equivalence’ (look-a-like). • There will be a ‘panel’ set up in Brussels to oversee the assessments made by the NBs (Notified Bodies such as BSI, British Standards Institute). • Manufacturers of legacy devices (yes, even the Exeter V40 stem) will have to undertake ‘clinical investigations’ around their products, on a regular basis, to keep their CE mark. • Manufacturers of some ‘Boutique’ implants, such as those primarily designed or DDH cases, might well withdraw them from the market on account of the expense involved. This won’t please some surgeons. Clinical investigations and going through a CE assessment is expensive.

Where will ODEP and BC fit with the MDR?

Well we think, with everyone’s co-operation, we can do a good job for patients and manufacturers alike.

ODEP

With the new MDR clinical data that will be needed by manufacturers to maintain their CE marks, we hope that the clinical data they submit to ODEP ‘will be a copy and paste job’.

Our European credentials increased about four years ago when hip, knee and shoulder surgeons joined ODEP from the Netherlands. The EPRD (German Registry) would also like to start sending delegates. For the past 2-3 years EFORT have been discussing introducing ODEP across Europe. Per Kjaersgaard-Andersen, recently president of EFORT, has been very keen to do this with Rob Nelissen, the chair of NORE (Network of Registries of Europe). In fact ODEP is already a global brand, (Figure 2).

Beyond Compliance

Beyond Compliance appears to fit with the aims of the new MDR. At present BC assesses implants as to their novelty and risk, besides monitoring them very carefully through NJR data, review meetings and our user group meetings. One consequence to the new MDR is that the ‘preclinical investigation stage’ is devoid of monitoring except by the manufacturer and the PI (Principal Investigator). Although manufacturers say that clinical trials are much stricter than they were in ‘metal on metal days’ there is still a strong feeling in many peoples’ minds that external validation is essential. This is massively supported by Cumberlege and we would concur. BC wishes to be available to manufacturers to oversee the pre-CE space if invited. BSI and TUV SUD, the two largest Notified Bodies in Europe support this initiative.

Figure 3a and 3b shows where BC fits at present.

With the new MDR, Figure 3b shows the period when there will not be external monitoring / validation. It is marked ‘Patients with a novel device’.

What we think we should now be offering is shown in Figure 3c and at present we are in a pilot stage.

Figure 3a: Current Beyond Compliance Service – Courtesy of Patrick Palmer (Northgate PS).

Figure 3b: Beyond Compliance Service Post MDR – Courtesy of Patrick Palmer (Northgate PS).

Figure 3c: Proposed New Beyond Compliance Service Pre-CE – Courtesy of Patrick Palmer (Northgate PS).

UKCA - United Kingdom Conformity Assessed

You are probably all aware that with BREXIT approaching HMG has decided that they will develop GB’s own version of the CE mark. It is the UKCA which is presently being developed by MHRA. The timetable is below:

• The UKCA will be used for certain goods, including medical devices, being placed on the GB market after the transition period. • From 1st July 2023, to place a device on the GB market, the UKCA mark will be required. • Manufacturers of Class I medical devices and general IVDs will be able to self-declare their conformity for the UKCA mark from 1st January 2021.

The CE mark will remain acceptable in the UK until 1st July 2023. Further advice is regularly updated at: www.gov.uk/guidance/regulatingmedical-devices-from-1-january-2021.

Figure 4: From 1st July 2023, medical devices will require the UKCA mark.

What will all this mean for manufacturers, ODEP and BC?

It must be the wish of manufacturers, that market both in the UK and EU, that a lot of the data the MDR will need, will be the same as that for the UKCA and we hope it will essentially be the same data required for ODEP and where appropriate, for BC.

Last January, ODEP and BC held a meeting in the MedTech Europe facility in Brussels which was attended by members of the Commission, notified bodies and the organisations representing manufacturers. The main purpose of the meeting was to flesh out the MDR in terms of the clinical investigations and monitoring of patients. At the end of the meeting we were asked to write up our recommendations for the new MDR. This opus has been accomplished and we do hope that it is going to be of value to the designers of the UKCA. Very shortly it will be on the ODEP and BC websites.

The demands of the MDR are very much in line with Cumberlege and one imagines Cumberlege will be mirrored in the UKCA.

UK plc

So do we want to make the UK a good place for the innovation and safe introduction of new implants? Back in 2011, Jeremy Hunt, the then secretary of state, made it clear that we must protect patients from disasters like Metal on Metal but ‘British Innovation’ must not go under.

It seems to us in ODEP and BC that we can help. The vast majority of joint replacements on the market work well. In BC we have discouraged some manufacturers from bringing some new implants, which we thought poor, to this country. We have initiated steps to improve the design or the use of others and some instruments have been improved following suggestions by surgeons at our user group meetings. However, by the fact we have reported mainly excellent results many implants are being taken up by surgeons and prospering.

ODEP does make it difficult for implants with poor results continuing in the market but promotes implants that do well.

If the UK is a difficult place to introduce new implants, there will be no encouragement for the joint replacement industry in this country and the multinationals will be reluctant to bring new devices to the UK. The USA will become the favourite place to launch new products.

So, what might all this mean for UK orthopaedic surgeons?

• For your favourite implants, outcome data and PROMS will be even more important. • Therefore, making sure all implant data is uploaded into the NJR is even more critical and making sure that PROMS data is captured in clinics and that patients are encouraged to complete follow-up PROMS questionnaires is equally critical. • We must also ensure that we all listen to our patients and report their concerns appropriately.

Resources

www.beyondcompliance.org.uk.

www.odep.org.uk.