Global Insight

by Steve Morgan

At the time of the last article on the implementation of the Medical Device Regulations (MDR), no one could have foreseen the challenges faced in the last year as a result of the Covid 19 pandemic, its impact on the global industry in general, and the introduction of the MDR in particular.

Medical device manufacturers have had to manage all of the complexities of social distancing in their day to day business, whilst dealing with a regulatory environment which was going to be extremely challenging even without Covid 19.

The purpose of this article is to give an overview of the current state of MDR implementation, drawing upon Contamac’s experience as a material supplier to the contact lens and intraocular lens industries.

The information provided in this article is intended to be for general guidance only.

All medical device manufacturers should seek advice from their notified bodies (NB’s) and follow the information and updates provided by the EU and UK regulatory authorities as it applies to your company, your location and your markets.

MDR Implementation Timing

The original date of MDR implementation was to be the 26^th May 2020 – however, the EU has delayed implementation until the 26^th May 2021 in response to the challenges posed by the pandemic.

Devices placed on the EU market with a certificate valid under the Medical Device Directive (MDD) can continue to be sold until either the certificate expires, or until 26^th May 2024, whichever occurs sooner.

Note that for medical devices certified to the MDD, elements of the MDR come into effect on the 26^th May, regardless of the duration of the existing certificate. These include Post Market Surveillance, Vigilance and Registration of Economic Operators and Devices.

All new product submissions under the MDR will have to comply with all relevant requirements from the date of implementation.

Status of Notified Bodies Designated Under the MDR

As mentioned in previous articles, the introduction of the MDR has also resulted in a much more rigorous assessment of NB’s by the national competent authorities. This led to many NB’s either withdrawing from the designation process or failing to meet the standards required by the competent authorities to assess against the MDR.

The current status is that, as of April 2021, there are twenty NB’s designated for the MDR based in eleven different EU countries (Germany 6, Netherlands 3, Finland 2, Italy 2, France 1, Slovakia 1, Hungary 1, Norway 1, Sweden 1, Ireland 1, Croatia 1).

It is worth noting that this figure has fallen by more than seventy in recent years, which emphasizes the workload to be undertaken by those designated NB’s.

Also, as NB’s are designated for certain medical device categories, the actual number designated for a specific type of medical device may be limited.

It is strongly recommended that manufacturers always review the relevant EU website for the latest information on designated NB’s.

Effect of Brexit on Medical Device Manufacturers

Following the UK’s withdrawal from the EU and the ending of the transition period, the rules for placing medical devices on the UK market and exporting medical devices into the EU have changed.

As the situation is very dynamic and reflects both political positioning and regulatory requirements, it is important that all manufacturers, whether based in the EU, UK or in a third country, closely follow the rules and regulations on the EU and UK websites.

1. Effect of Brexit on Exporters from the UK to the EU

The following general points should be noted:-

• Currently, there is NO reciprocity agreement between the UK and the EU with regard to the EU recognizing CE approvals awarded by UK based NB’s.
• A UK manufacturer must use an EU based NB designated to the MDR to obtain certification of their medical device if they wish to place it on the EU market.
• A UK manufacturer will also have to appoint an EU authorized representative who is physically located within a member state of the EU.

2. Effect of Brexit on Importers from the EU to the UK

Note that Northern Ireland has several unique requirements compared to the rest of the UK concerning imports from the EU, which may be subject to change. See UK / EU websites for the latest information.

• The Medicines and Healthcare products Regulatory Agency (MHRA) is the body responsible for regulating the UK medical devices market.
• Medical device certificates issued by EU-recognized Notified Bodies WILL continue to be recognized by the MHRA for the Great Britain market until 30 June 2023.
• EU approved medical devices will need to be registered with the MHRA to allow continued placing of devices on the UK market.
• The MHRA are in the process of establishing the requirements for UK based Authorized Bodies who will fulfil the role of NB’s in the future.
• The UK Conformity Assessed (UKCA) mark is the new UK product marking that will be required for all medical devices being placed on the market in Great Britain (England, Wales and Scotland).
• The MHRA is still developing the process and requirements by which devices will obtain UKCA approval. All manufacturers are recommended to follow updates on the MHRA website.

Practical Aspects of Complying with the MDR

From the feedback received, it appears that many device manufacturers are facing significant challenges in meeting the requirements of the MDR in key areas, including:-

• Timing
• Costs
• Supporting data for legacy products
• Custom made devices
• Post Market Surveillance (PMS)

Looking at these in more detail:-

1. Timing

For manufacturers who already have a contract with a designated NB, the process of obtaining CE approval under the MDR is still a lengthy process, often taking 12 months or more from submission to approval. It is also important to note that for manufacturers who have not yet negotiated a contract with an NB, there may well be delays in reaching an agreement, as NB’s are still suffering from resource constraints. As such, NB’s are often giving priority to existing customers who are seeking certification transfer from the MDD to the MDR. Manufacturers with existing CE approval under the MDD need to factor in the timings carefully, to avoid delays in transitioning from the MDD to the MDR, which would prevent them from placing further devices on the market within the EU.

All of the above does not take into account any additional ongoing delays due to the pandemic, which may impact the ability of auditors to visit manufacturing facilities, although some progress is being made on the acceptance of remote audits by the regulatory authorities.

2. Costs

The cost of approvals has increased for a variety of reasons, including:-

• The process of technical file review, correcting deficiencies and conducting audits of the manufacturing facility by NB’s, are now going to take longer and so will cost more to complete.
• Additional costs will be required to undertake more up-to-date biocompatibility testing as defined in the latest revisions of ISO 10993 – Biological Evaluation of Medical Devices. In addition, the range of tests required may also increase following the introduction of the MDR.

As a result, many manufacturers are evaluating the business case for the additional expenditure to gain certification under the MDR. It is possible that some manufacturers will reduce the range of medical devices sold, concentrating on the most profitable lines only.

3. Supporting data for legacy products

There is no acceptance for “grandfathering” legacy products under the MDR. When certification to the new standard is required, the information provided in the technical file needs to represent the “state of the art”. While there is no absolute definition of the meaning of state of the art, it is often being interpreted by NB’s as meeting the latest published standards relevant to the medical device in question.

4. Custom Made Devices

The EU has published further guidance on the subject of custom made devices. It implies that only devices which are completely made to order in response to a specific written prescription for the patient can be considered as a custom made device that is exempt from the need to CE mark.

It is important to note that this does not include “made to order” devices, which are interpreted as being “patient-matched” or “adapted” from devices that may be semi-finished or in some other way partially manufactured. Confusingly, this category can also include lenses for which a patient prescription has been supplied.

The impression is gained that the regulatory authorities are tightening up on the definition of a custom made device to prevent it from being used as a loophole to avoid CE certification. If any manufacturer believes that their products are custom made devices, it is strongly recommended that you start a dialogue with your NB at the earliest opportunity to ensure the planned approach will be accepted under the MDR.

5. Post Market Surveillance

From the date of implementation of the MDR (26^th May 2021), medical device manufacturers will have to have an integrated post market surveillance (PMS) system established within their overall Quality Management System. This applies to medical devices which are approved under the MDD and for which a valid CE certificate remains in place. Depending upon the classification of the device (and therefore the perceived risk) the post market surveillance requirements can include:-

• Post Market Surveillance plan
• Post Market Surveillance report
• Periodic Safety Update report

Again, manufacturers should engage with their NB to ensure that they are compliant with the new requirements.

Summary

With the imminent implementation of the MDR within the EU, it is clear that medical device manufacturers still face major challenges to meet the requirements in a timely manner to support their business plans. The regulatory path for those manufacturers based in and supplying the EU is clearer, but it is still constrained by resource limitations in NB’s. For those manufacturers supplying the UK market, the regulatory path is still evolving.

As previously recommended, device manufacturers must engage with their notified bodies to ensure they remain aligned with the requirements for the markets they are supplying.

Disclaimer – This article is intended for information only. It does not constitute an official or agreed position of Contamac Ltd. The views expressed are entirely those of the author.

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Do you need IFU guidance for your Medical Device?

Have a look at this guide for creating IFU for Medical Devices*. Includes European and USA requirements.

*Contamac is not responsible for the information provided in this guide. Please use at your own discretion and follow the regulations as indicated by your notified body (NB).