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Racing Towards UKCA Compliance: Expert Ed Ball, Senior Associate, RQM+ – A Professionals View

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UKCA Compliance, By Ed Ball, Senior Associate, RQM+Author:  Ed Ball, Senior Associate, RQM+

UKCA Compliance: Medical device manufacturers have been under pressure for a while now, trying to ensure they are compliant with the EU Medical Device Regulation (MDR) and the upcoming In Vitro Diagnostic Regulation (IVDR). That pressure is not about to ease up as the UK’s exit from the European Union (EU) has introduced a new set of regulatory requirements.

The UK will continue with the UK Medical Devices Regulations 2002 (S.I. 2002/618) (UK MDR), as amended, and by the 30th of June 2023, manufacturers will need to follow the UK Conformity Assessment process and place the UKCA mark on their medical devices, as CE marked medical devices will stop being recognised in Great Britain (England, Scotland and Wales). CE marked devices will continue to be accepted in Northern Ireland, as the EU MDR and IVDR will apply from their respective dates of application.

The conformity assessment processes defined in the UK MDR 2002 (as amended) results in the medical device carrying the UKCA mark (for GB) or UKNI mark (for NI). If devices are intended for Northern Ireland but nowhere else in the EU, then the device can bear the UKNI mark instead of the UKCA mark. In addition to this, all medical devices on the UK market must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA).

With so many efforts placed first on achieving EU and now UK compliance, it is critical that businesses identify and seriously evaluate any potential overlap in the preparation towards these different regulations to ensure they remain efficient. This understanding will eliminate duplication of effort, help identify gaps in data and documentation and can even drive medical device manufacturers to set their strategy for the coming years as well as make product portfolio decisions regarding the UK and EU markets.

Depending on various factors (how far along the EU MDR or IVDR compliance process was, the classification of the product and more), businesses will need to funnel more resources and investment in complying with UK regulation. Taking stock of the compliance progress made to date and comparing requirements will help achieve efficiency and faster times to market. Based on compliance risk, classification, CE mark status, UK regional sales and level of preparedness, manufacturers will be able to make effective decisions on whether or not to pursue the UKCA mark for all the product categories they currently supply to Great Britain and Northern Ireland.

One of the most anticipated risks is that posed by time; as of the 1st of January 2021, the UK conformity assessment for certain device classifications will depend on UK Approved Bodies, rather than the EU Notified Bodies. There are currently only three UK Approved Bodies to manage all the demand, so a bottleneck looms large. Savvy businesses should engage with a UK Approved Body early to ensure they are able to get their UKCA mark in time. Alternatively, those manufacturers who use EU Notified Bodies with no formal presence in the UK currently should open the dialogue with their Notified Body to determine their intentions. If they plan to establish themselves as a UK Approved Body, then it may be prudent to wait for their entry and maintain the relationship with the same organisation rather than using different certification bodies for the EU and the UK.

The key to not becoming overwhelmed by this new onus is planning ahead. Making the most of the ‘standstill’ or transition period, ahead of the 2023 deadline, could help ensure that manufacturers hit the ground running. At the same time, it is important not to rush the task without strategy and to take advantage, for example, of the different deadlines for registering devices with the MHRA depending on their classification. High risk devices needed to be registered by 30th April 2021, moderate risk devices by 31st August 2021 and low risk devices by 31st December 2021.

Another area where non-UK manufacturers would do well to move in early is the appointment of a UK Responsible Person (UKRP). Roughly equivalent to the EU Authorised Representative, the UKRP will need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). Their name and registered place of business will appear on the device labelling, next to the UKCA mark. Non-UK manufacturers should have had a UKRP in place as of 1st January 2021 and must have a UKRP in place at the time of registering their devices with the MHRA.

Businesses will need to invest time and resources in ensuring they remain up to speed on numerous changes such as newly listed UK Approved Bodies, implementation of policy advice from the Cumberlege Review, potential fast-track conformity assessments for CE-marked devices, liability insurance issues, the publication of new versions of standards listed as designated standards, labelling, documentation and data exchange protocols, as well as any emerging UK-EU equivalency.

Updated guidance on conducting clinical trials, especially across multiple sites in different countries, is also likely to evolve during the transition. Manufacturers carrying out clinical trials in the UK will need to review guidance on topics such as submitting safety reports, making substantial amendments to clinical trials, and new MHRA guidance.

Similarly, the treatment of patient data is another area that is in flux. As more and more ‘sensitive’ information needs to move between the UK and the EU, UK data protection rules and GDPR will need to be monitored closely. Staying abreast of new developments by following information from the relevant authorities will need to be added to the new onus of administrative tasks such as import and export administration.

Special attention needs to be paid to documentation and flows of information with new partners and parties; in particular, once the process of sourcing a UKRP has been addressed it is important to understand how to manage certification and documentation with them as part of establishing the relevant agreements with that UKRP. Similarly, businesses would do well to establish how best to plan, resource and schedule the UKCA labelling and Instruction for Use (IFU) transition as well as understanding how to deal with import/export controls and documentation rapidly and cost-effectively.

We are presented with a highly dynamic and fragmented regulatory landscape that is set to develop further throughout the ‘standstill’ or transition period. While UK regulations have provided a valuable opportunity to address concerns relating to medical device safety, as indicated in the Cumberlege review, significant challenges lie ahead. Starting with the plans to appoint a Patient Safety Commissioner (PSC) as recommended by the review, through to new guidance documents expected from the MHRA, there is an unprecedented opportunity to review product portfolios, thus improving patient safety but also competitive advantage.


Ed Ball, Senior Associate at RQM+

Ed Ball formerly worked as a medical device specialist at the UK Medicines and Healthcare products Regulatory Agency (MHRA), and is currently an active member of the UK’s Technical Committees for Medical Device Quality Management and Risk Management standards. He is an accomplished medical device specialist and chartered engineer, who combines a technical understanding of medical devices with regulatory and quality management experience. Ed has 15+ years of practical experience with a wide breadth of medical devices, including but not limited to EU Class I – III, active devices, implantable devices, diagnostic devices, measuring devices, devices used by lay people, and sterile devices.

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Medical Devices

What Kind of Equipment is Used to Analyze DNA?

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Below are some of a few basic processes followed throughout DNA testing. The general procedure entails: 

Isolating DNA from a sample containing the needed DNA of unknown origin, as well as isolating DNA from the test sample (e.g., blood, semen, skin tissue, or saliva) from a known individual.

Processing the DNA to obtain test results,

 Determining the variations in the DNA test results (or types) from specific regions of the DNA, 

Comparing and interpreting the test findings from the unknown and known samples to have a conclusion.

How is DNA Analyzed?

The DNA sample is taken to a forensic laboratory. These labs differ significantly in terms of how they have been organized and the kind of analyses they provide. Many laboratories can test nuclear DNA, which is the copy of DNA found in every cell’s nucleus. However, specialized procedures such as mtDNAanalysis and Y-chromosome among others are only available in a few sophisticated labs. Let us take a closer look at a few of these strategies.

Restriction Fragment Length Polymorphism (RFLP)

One of the first forensic approaches for analyzing DNA is restriction fragment length polymorphism (RFLP). It measures the length of DNA strands with repeating base pairs. Variable number tandem repeats (VNTRs) is a type of repetition that can occur anywhere between one and thirty times.

Process: To do RFLP analysis, researchers must dissolve DNA in an enzyme that breaks down the strand at specific locations. The length of each strand of DNA is affected by the number of repeats. The investigators compare the sizes of the strands in the samples. RFLP analysis requires a piece of uncontaminated DNA for the best and accurate results. 

Short and Tandem Repeat Analysis (STR)

RFLP analysis is slowly being phased out in favor of short tandem repeat (STR) analysis in many laboratories. One of the most significant benefits of this technology is that it can begin with a considerably smaller quantity of DNA. 

STR analysis evaluates the frequency of repeat of base pairs in specific segments on a DNA strand after DNA amplification. Repeats of two, three, four, or five base pairs are known as dinucleotide, trinucleotide, tetranucleotide, or pentaLetnucleotide repeats. Investigators frequently look for tetranucleotide or pentanucleotide repetitions in PCR-amplification samples because they offer high accuracy.

Process: The sample is amplified using a polymerase chain reaction technique. PCR copies DNA similarly to how DNA duplicates itself in a cell, yielding nearly unlimited amounts of genetic material by using agarose gel media.

Importance of DNA Analysis:

DNA analysis’s primary goal is to create a visual representation of DNA. A DNA “image” resembles a fingerprint taken from a flat surface with columns of dark-colored parallel bands, and it is unique to every individual. The DNA “fingerprint,” or profile, of a DNA sample, must be compared, either to DNA from a suspect or to a DNA profile kept in a database, to identify the sample’s owner.

Equipment Used to Analyze the DNA:

DNA testing investigates several loci in human DNA when investigating possible a match. Human DNA differs by around one-tenth of one percent, or roughly three million base pairs (a person has three billion in total); therefore, you must identify highly variable regions. Sterile cotton swabs are the most commonly used tools to collect samples because they limit the possibility of contamination. However, you can study any fluid or tissue from any item or object. Some of the lab equipment used in DNA analysis include: 

Thermostatic Cycler:

There are different equipment used for each procedure. A thermal cycler holds a block of tubes carrying PCR mixture. It raises or lowers the block’s temperature in pre-programmed steps, as used in PCR (polymerase chain reaction), a common technique in DNA analysis. This splits and amplifies the DNA, resulting in multiple copies of the same strand. The approach is used to evaluate even little or deteriorated materials. The DNA, on the other hand, must still be tested.

DNA Analyzer:

To detect particular nucleotide sequences, a DNA probe labeled with a radioactive molecular marker may bind to a complementary DNA sequence in the sample resulting in a unique pattern for each person, which can then match a different sample. 

It is more likely that scientists will find a match if there are more loci present. The recommended number is approximately four to six probes. After that, the amount of time and money spent on testing skyrockets.

Dyes and Electric Fields:

After amplification, another approach referred to as short tandem repeat (STR) is implemented. This process involves the use of either gel electrophoresis or capillary electrophoresis. Both methods use an electric field to see any repetitive DNA sequences across 13 distinct loci. Researchers can use silver staining, intercalating dyes like ethidium bromide, or fluorescent dyes to make the sequences more visible. The chances of two people having an exact match are roughly one in a billion, which means only approximately six or seven people on the planet will have a match.

DNA Isolation Kits:

Most molecular biology procedures, such as cloning, library preparation, and sequencing, need plasmid DNA purification as a starting material. There are ready-to-use plasmid purification kits and reagents to extract high-quality plasmids from bacterial and fungal cell types, such as those offered by Modern Biology. Select the purification scale (from miniprep to gigaprep), format (spin, vacuum, or magnetic), and compatibility with automated systems using the specified filters. 

Polymerase Chain Reaction Machines (PCR)

When you’re able to make several copies of a DNA segment, you can conduct various tests at the same time. You may, for example, run one test after another without causing the original sequence to be damaged. You may create a control segment and then compare it to other segments. A single tissue sample may be submitted, and numerous test results can be obtained. This is made possible by the polymerase chain reaction machine, which is why it is standard equipment in DNA analysis laboratories. 

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Medical Devices

mJOULE Launches in the United Kingdom Reports Sciton

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 “At Sciton, we work hand in hand with our clinician partners to drive visionary innovation that is founded on science and uncompromised quality,” shares Aaron Burton, Sciton CEO. “We are proud to be leading the industry with new product innovation and enhancements that benefit practices and patients alike.”

mJOULE is a dual wavelength platform that features BBL HERO and MOXI technologies, created in response to a changing market which desires less time consuming treatments, yet equally strong outcomes. Recently honored by NewBeauty as a 2020 ‘Innovation Award Winner,’ BBL HERO (High Energy Rapid Output) is the fastest, most powerful IPL in the industry, and empowers practitioners to treat the entire body with four times the speed, three times the peak intensity, allowing for a highly customizable protocol. The treatment results in smoother, clearer, younger and healthier looking skin in just one to two sessions.

“Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide.” says Lacee J. Naik, Vice President of Marketing and Public Relations.

The second technology available on the mJOULE platform is Sciton’s newest fractional laser, MOXI. MOXI is one of the most inclusive laser treatments available, and is safely suitable for those higher on the Fitzpatrick scale. This non-ablative laser addresses sun damage and aging, takes under 20 minutes and boasts little to no downtime, allowing it to fit comfortably into even the busiest of schedules and can be performed any time of the year.

“The U.K. is an important market for Sciton’s global growth strategy,” says David Percival, Vice-President and General Manager for Sciton International. “We see a tremendous opportunity to introduce both these novel technologies into the growing aesthetic market in the U.K.  We have a strong reputation for delivering an outstanding customer experience and look forward to expanding our Sciton family of customers.”

Sciton will celebrate this monumental international launch with a premier event in London on June 24th, 2021, where staff, partners, and leadership will gather to recognize this milestone and officially welcome their ground-breaking technologies to the dynamic UK market.

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Source: https://infomeddnews.com/mjoule-launches-united-kingdom/

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Medical Devices

Sciton Celebrates the Newest Innovation in United Kingdom: Sciton’s mJOULE

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Exceptional Outcomes Now Available Overseas

LONDON, June 18, 2021 /PRNewswire/ — Sciton® Inc., a leading manufacturer of medical and aesthetic lasers and light source technologies based in Palo Alto, California, announces the launch of its latest platform, mJOULE, in the United Kingdom. This revolutionary system features some of the biggest updates in the history of pulsed light based technology, including its newest fractional treatment, MOXI, and the award-winning BBL HERO treatment.

Sciton® Inc., announces the launch of its latest platform, mJOULE, which includes MOXI and BBL HERO in the UK.

“At Sciton, we work hand in hand with our clinician partners to drive visionary innovation that is founded on science and uncompromised quality,” shares Aaron Burton, Sciton CEO. “We are proud to be leading the industry with new product innovation and enhancements that benefit practices and patients alike.”

mJOULE is a dual wavelength platform that features BBL HERO and MOXI technologies, created in response to a changing market which desires less time consuming treatments, yet equally strong outcomes. Recently honored by NewBeauty as a 2020 ‘Innovation Award Winner,’ BBL HERO (High Energy Rapid Output) is the fastest, most powerful IPL in the industry, and empowers practitioners to treat the entire body with four times the speed, three times the peak intensity, allowing for a highly customizable protocol. The treatment results in smoother, clearer, younger and healthier looking skin in just one to two sessions.

“Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide.” says Lacee J. Naik, Vice President of Marketing and Public Relations.

The second technology available on the mJOULE platform is Sciton’s newest fractional laser, MOXI. MOXI is one of the most inclusive laser treatments available, and is safely suitable for those higher on the Fitzpatrick scale. This non-ablative laser addresses sun damage and aging, takes under 20 minutes and boasts little to no downtime, allowing it to fit comfortably into even the busiest of schedules and can be performed any time of the year.

“The U.K. is an important market for Sciton’s global growth strategy,” says David Percival, Vice-President and General Manager for Sciton International. “We see a tremendous opportunity to introduce both these novel technologies into the growing aesthetic market in the U.K. We have a strong reputation for delivering an outstanding customer experience and look forward to expanding our Sciton family of customers.”

Sciton will celebrate this monumental international launch with a premier event in London on June 24th, 2021, where staff, partners, and leadership will gather to recognize this milestone and officially welcome their ground-breaking technologies to the dynamic UK market.

ABOUT SCITON
Sciton, Inc., located in Palo Alto, California, is an employee-owned medical device company established in 1997 by co-founders Jim Hobart, Ph.D., and Dan Negus, Ph.D. Sciton is committed to providing best-in-class laser and light solutions for medical professionals who want superior durability, performance and value. Sciton offers aesthetic and medical devices for women’s health, fractional and full-coverage skin resurfacing and skin revitalization, phototherapy, vascular and pigmentation lesions, scar reduction, acne, body contouring, and hair reduction. Sciton operates on a worldwide basis with direct sales teams in the United States, Canada, Australia, United Kingdom, Ireland, Japan and distributor partners in more than 45 countries. For more information, and a complete listing of Sciton systems, visit www.sciton.com.

Facebook: @ScitonInc
Instagram: @Sciton_Inc
LinkedIn: @ScitonInc

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/sciton-celebrates-the-newest-innovation-in-united-kingdom-scitons-mjoule-301315294.html

SOURCE Sciton, Inc.

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Medical Devices

Avanos Medical, Inc. to Present at the 2021 Raymond James Human Health Innovation Conference

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ALPHARETTA, Ga., June 18, 2021 /PRNewswire/ — Avanos Medical, Inc. (NYSE: AVNS) today announced that Joe Woody, chief executive officer, will present and participate in an analyst-led fireside chat at the Virtual 2021 Raymond James Human Health Innovation Conference Tues., June 22 at approximately 10:40 a.m., ET.

A live webcast of conference presentation will be available on the Investors section of the Avanos Medical website and will be archived on that site.

About Avanos Medical:
Avanos Medical (NYSE: AVNS) is a medical technology company focused on delivering clinically superior breakthrough medical device solutions to improve patients’ quality of life. Headquartered in Alpharetta, Georgia, Avanos is committed to addressing some of today’s most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Avanos develops, manufactures and markets its recognized brands in more than 90 countries. For more information, visit www.avanos.com and follow Avanos Medical on Twitter (@AvanosMedical), LinkedIn and Facebook.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/avanos-medical-inc-to-present-at-the-2021-raymond-james-human-health-innovation-conference-301315265.html

SOURCE Avanos Medical

Company Codes: NYSE:AVNS

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