Clinical & Regulatory

Clinical & Regulatory

But what does it really mean? The EU’s new diagnostics and medical devices regulations examined



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The many concerns circulating while we waited for new regulations to be finalised may well have deterred some companies from coming to Europe. And politically, the world has moved in a direction nobody could have predicted. What does it all mean and how’s best to prepare for this new world?

MDR IVDR

It’s been a long eight years getting to the moment when the European Parliament finally voted to endorse the new revised regulations on Medical Devices and In Vitro diagnostics, first written in the early 1990s. In that time concerns and fears have grown about their possible impact on medtech companies wanting to bring their products to market. These fears include increased costs and lengthier, more complex application processes for certification by Notified Bodies (NBs). In addition, there have been worries about possible punitive fines after unannounced factory inspections on any companies failing to meet standards and comply with safety regulations were announced?

THE FACTS

  • The new rules will strengthen the surveillance of Notified Bodies by national authorities.
  • They set out explicitly manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices on the market, including annual updates of Clinical Evaluation Reports (CER).
  • A central database will be set up covering economic operators, notified bodies, market surveillance, vigilance, clinical investigations and certificates.
  • The official timings for transition start 20 days after the new laws are published in the Official Journal. This is expected early May, so official transition should start around 1st
  • The Regulations will be fully applicable in three years for medical devices and in five years for in vitro diagnostics medical devices.
  • Stakeholders are to be consulted on drawing up an ‘implementation roadmap.’
  • For the medical device sector, the new regulation is a modernisation of the original rules, bringing together best practices from existing Commission guidance.
  • For the in vitro diagnostics sector, this is a major overhaul of the rules. There is still a need for all parties to work together on the needed secondary legislation and European best practice guidance to meet the transition deadline. Industry has already pointed to several priority areas including classification, conformity assessment, clinical evidence and the early availability of notified bodies.

MedTech Europe has welcomed the new Regulations and announced ‘successful implantation’ of them will be ‘a key priority.’ They have also welcomed the European Commission and national Competent Authorities’ initiative to consult stakeholders in developing an official implementation roadmap.

It’s important to ensure all players – authorities, notified bodies and economic operators – can successfully transition to the new Regulations, they added.

Serge Bernasconi, MedTech Europe’s CEO, said: ‘A lot of work has gone into these regulations and there is still a lot to do to make them a reality. The amount of effort needed from all parties to implement these revised rules cannot be underestimated.’

The three-year transition period is tight. Industry has highlighted for priority the following areas for agreed clarity:

  • The transition provisions
  • The updated clinical evaluation requirements
  • The new ‘scrutiny’ process, and
  • The early availability of Notified Bodies.

It’s hoped the MDR and IVDR regulations will ensure a level playing field for the 25,000 medical devices manufacturers in the EU, many of which are SMEs that employ more than half a million people.

But MedTech Europe has warned it’s vital that in vitro diagnostics and medical devices are given the equivalent level of attention and investment during the development of necessary secondary legislations and European Commission guidance. And they have called for ‘pragmatic solutions be found to address the Notified Bodies’ capacity to handle the enormous flow of new and renewal dossiers that these regulations trigger.’ If implemented successfully, the new regulations will better guarantee the safety of medical devices to the public, and should ensure that the 2010 PIP breast implants scandal never happens again.

To gauge the extent of challenge that many companies will face, we spoke with Emilie Fournier, consultant at Isocèle Conseil, Basel.

MTE: How many companies do you think may need consultancy help in complying with the new regulations?

EF: This transition to MDR and IVDR impacts on all the manufacturers, as all CE marking certificates will become obsolete between 2020 and 2025, depending on the products. Transition strategies and timings will be different from one product to the other, of course, but one can average that all MD products will need to be re-certified according to the new regulations in a four- to six-year timeframe. It is therefore very likely that a majority of companies, especially SMEs, will seek external support for two reasons. Firstly, for training on and understanding of how to interpret new regulations, and secondly to fill a lack of resources needed for the implementation of new regulation requirements.

Which sort of companies are most likely to help, in what areas?

Consulting companies will have a major role to play in this transition by providing guidance, supporting transition planning and also in sharing audit feedbacks and lessons learnt. Dialogue with newly certified Notified Bodies and with health authorities will be key to understanding the NB’s expectations and interpretations of the new regulations. Facilitators, such as consulting companies, and others, will be much needed to move forward as smoothly as possible.

The new MDR and IVDR

A year before the new MDR and IVDR texts would enter into force, we weighed up what the ongoing negotiations meant for safety, innovation and the future of European medtech.

READ ARTICLE

How much time, on average, do you think companies can save in bringing their products to market?

From a short-term perspective, product launch might be impacted by the expected poor availability of Notified Bodies. The current timeframe to obtain a CE marking when an audit is needed is approximately six to 12 months. One can expect a longer delay because of an expected decrease in the number of NB’s, combined with an increase in certification/re-certification demands.

Regulatory strategies will have to be carefully defined to anticipate the future as much as possible. For instance, a new class I device launched in 2017 under the directive 93/42 might fall into a higher class according to the next MDR/IVDR, for which certification by a NB is required together with the implementation of an appropriate QMS. Preparation for the next steps will be key to keeping the product on the market.

Do you have any concerns about the new regulations, how the roadmap to implementation will be drawn up, or the timescales to implementation?

Anticipation is key in this transition process. The 2019-2025 period will be highly challenging for the medical device industry, for sure. All the NBs need to be accredited again according to new regulations. This re-accreditation process can start six months after the official texts are published and is planned to take about a year, meaning that Notified Bodies will be ready for auditing in 2019. Therefore, the three years transition period is in fact reduced to one until the current directives disappear.

Emilie Fournier

Emilie Fournier

Companies will have to prepare for a new certification in 2019. For the products already CE marked, updates on clinical safety and post-market surveillance for instance will be needed anyway. The product can stay on the EU market with an ‘old’ CE marking until 2025 at the latest, depending on the product. The timelines for transition will have to be set on a case-by-case basis. As classification rules change, some products currently considered as Class I or even not in the scope of the directive (eg. aesthetic lenses) or under auto-certification process (eg IVDs classified as ‘others’) might be upgraded to higher classes for which certification by a NB will be required. Again, every manufacturer must perform proper due diligence to adapt their regulatory strategy and quality systems accordingly.

Another of the main changes to come is the implementation of the European database, EUDAMED, and the implementation of the IUD system. As of now, the operational structure and procedures have not been communicated. Jumping into this new system will probably take time until being fully operational.

Will the regulations make it easier or harder to bring new technology products to market?

Several new technologies are now defined in the MDR (eg nanomaterials, borderline devices) and were not in the directives, in that sense, it is a first step to get a better understanding of the requirements. This goes along with a reinforced stringency on technical documentation content and management expected from the NBs. Overall, the implementation of the MDR is a significant change for all marked products, based on new/emerging technologies or not. One can expect that bringing new technologies onto the market will not necessarily be easier in this context of massive regulatory changes.

What are the practical problems for the follow-up of inspection of quality, performance and safety of devices on the market, including annual updates of Clinical Evaluation Reports (CERs)?

Manufacturers of CE-marked devices according to the MD directive 93/42/CE will have to update some of their processes and procedures, especially for post-market surveillance and post-market clinical follow-up during the transition period (mid 2017 to mid 2020) in order to get ready once the directives are fully replaced by the MDR and IVDR. Operational modalities for the submission of the annual CERs for review as well as the expected format or precise expected content are not yet defined. This will clearly be challenging for the authorities and the manufacturers.

One additional aspect to consider is the foreseeable need in resources, both financial and human, needed to ensure regulatory activities. The MRD requires a regulatory responsible person to be identified in the company to be in charge of product release, among other tasks. Additional requirements (CERs, vigilance etc) will require additional resources and increased costs have to be anticipated, especially for SMEs.

About the author

Jenny Sims is a freelance writer and editor specialising in healthcare management and policy. Follow her at @Jenny__Sims.

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