European Medical Device Regulation (EU MDR) brings significant changes to the medical device industry, with new classification rules topping the list.
It is less than one year until the end of the European Medical Device Regulation’s (EU MDR) transition period – May 26, 2020 – and Class I manufacturers cannot afford to fall behind on compliance. Now is the time to act and comply with the new regulation to ensure proper certifications are issued to continue to sell products in the EU market.
Lack of urgency in complying with the new regulation may be due to manufacturers’ misperceptions, such as the assumption that only industry competitors manufacturing high-risk devices are required to conform with the EU MDR. Dispelling this myth could not be more crucial.
The new EU MDR brings significant changes to the medical device industry, with new classification rules being one of the most important. For Class I manufacturers to face the impending challenges, the following points help provide a clear pathway to compliance.
Publication of the MDR in 2017 opened a new chapter for manufacturers trading in the EU market. The MDR establishes that within the three-year transition period, all manufacturers will have to fall under one of three obligations to continue trading products in the EU. Manufacturers can re-certify under the Medical Devices Directive (MDD) or self-certify under the new requirements of the MDR, while manufacturers producing up-classified devices will need notified body review before the deadline. The first obligation states that if a product is recertified under the MDD (before May 25, 2020) manufacturers can take advantage of an extended transition period until May 2024. However, Class I devices have no EU certificate so there is no extended transition period and all new MDR requirements apply immediately on May 26, 2020.
Another change that Class I manufacturers need to consider is that regulations previously didn’t require a formal Quality Management System (QMS) under MDD, but starting on May 26, 2020, all manufacturers will require a formal QMS as per MDR Article 10, paragraph 9, best served by implementing EN ISO 13485:2016.
MDD and the MDR present significant differences that Class I manufacturers should not overlook. Under the MDD, non-sterile Class I products without a measuring function can obtain CE-marking through self-certification in accordance with Annex VII.
Although Class I manufacturers can certify conformity of their own products through the EU declaration of conformity (MDR Article 19), they will still need to provide a comprehensive and detailed technical file. Self-certification conditions within the MDR are well defined; if the device doesn’t require a classification change and stays a Class I product, manufacturers can then continue to self-certify as long as they fulfill MDR requirements. The accuracy of their technical documentation must meet these requirements in time for the deadline, as well as self-declare the conformity of the devices with the requirements and register those details on the EUDAMED database.
The MDR increases classifications from 18 to 22 – new regulations establish new classifications – and includes important changes to current rules. Reusable surgical instruments are a prime example. Although they are already Class I and don’t require notified body review, they will fall under a new classification of Class I devices – Class Ir (reusable surgical instruments) – and this classification requires a notified body to look at cleaning, repackaging, and reprocessing elements.
To have a clear idea of where new classifications apply and how new conformity assessment routes are changing, manufacturers need to fully understand MDR Annex VIII. Devices that have been up classified to Class IIa or IIb, Class III, or any subsection of Class I, will have to seek notified body review for certification. It’s fundamental that Class I manufacturers don’t underestimate the required additional input, time, preparation, and resources required to demonstrate total EU MDR compliance.
Be aware of the significant deficiency of notified bodies across Europe, causing a shortage of regulatory expertise. Manufacturers failing to act now risk not knowing if their device has been up classified, subsequently risking their notified body already operating at full capacity and unable to review their technical documentation in time for the deadline.
The EU MDR does not allow for grandfathering products. Even if a device has been on the market for two decades it requires a new CE mark to comply with the MDR. While manufacturers wait for notified bodies to be designated under the MDR, they should be working on sourcing the appropriate clinical evidence for their devices to be CE marked. If devices do not meet compliance standards by May 25, 2020, they will be removed from the market and manufacturers won’t be able to gather the appropriate clinical evidence the MDR requires.
Additionally, Class I manufacturers will need to draw up a formal Post Market Surveillance (PMS) report and include it in their QMS. Once the PMS has been put together it’s the manufacturer’s responsibility to keep it up to date with the latest clinical evidence. Acting now means that already available post-market clinical data can be used; moreover, a post-market study can be performed and submitted as clinical evidence within the technical documentation.
MDR compliance needs to be at the top of manufacturers’ priorities, otherwise they face being locked out of the EU market, risking cash-flow repercussions and business reputations. The clock is ticking and the advantages of early compliance to the EU MDR should not be underestimated by Class I manufacturers.
About the author: Peter Rose is Maetrics’ European managing director and can be reached at 877.623.8742.
Carbide inserts, strong coatings; Multiple small workpieces, single machine setup; OEE, data collection software
TFX front turning carbide inserts (wiper style available) with up to 0.197" depth of cut in a single pass, incorporate a special chip-breaker with sharp cutting edge for chip control and surface finishes. TFT series holders have rigid side screw clamping for stable turning, preventing insert movement from Z-directional cutting forces. Pair the TFX inserts with a coolant-through holder (TFT...-OH2) to improve chip evacuation, surface finish, part tolerance, and tool life. The -OH2 style holders are compatible with new coolant-through gangs (Citizen L20 & D25 CNC machines).
TFX inserts are available in DM4, for titanium, cobalt chrome, heat resistant alloys, stainless steels, and now in ST4, a super- tough PVD-coated carbide grade. The CrAlN coating provides high hardness and resists oxidation, solving issues related to machining materials such as 304SS, 17-4PH, and Nitinol.
The Kentucky-built VCN-570C various range spindle options, allows shops to balance speed and torque for machining needs and workpiece materials. A 1,659ipm traverse rate in the X-, Y-, and Z-axis also improves productivity. A servo-driven automatic tool changer can be combined with an optional 60-tool magazine to deliver more part-processing versatility through reduced tool setups and more spindle uptime.
ShopFloorConnect OEE and Shop Floor Data Collection software gather data from every machine in a manufacturing operation, displaying results in real-time for detailed overall equipment efficiency (OEE) reports in a variety of formats. Identifying and quantifying excessive production losses and bottlenecks can reduce machine downtime by 70%.
ShopFloorConnect Version 6.0 offers dashboard customization, flexible scheduling capabilities, and machine interface enhancements. Users can improve machine OEE by tracking reasons for scrap, and Version 6.0 allows users to manually enter good and bad part count data.
Iscar Metals’ R&D investment delivers medical machining solutions through unique geometries, tools, and grades.
Miniature dental and medical components present a formidable, yet dynamic, challenge to cutting tool manufacturers. Enterprising surgeons and dental professionals, collaborating with medical device implant companies, are advancing and revolutionizing medical procedures.
However, each new device requires correspondingly advanced tools and geometries to precisely create complex shapes while ensuring consistent surface finishes.
Most medical screws and implants are produced from titanium superalloys, although stainless-steel hard materials are used when a special ratio of depth-of-cut (DOC) to chip thickness is required. Titanium and stainless-steel materials are gummy and cause built-up edge (BUE), which wears down edge sharpness. High temperatures generated during chip breaking shorten tool life and damage surface quality.
Iscar’s custom tool assemblies built to the ISO 13399 standard provide cutting tools for these parts – specifically dental screws and four components for hip joint replacement implants: femoral head, acetabular shell, femoral stem, and bone plate.
SwissCut, used for turn threading, reduces setup time and eases indexing without removing the toolholder from the machine. Inserts are equipped with chip deflectors for machining small parts.
SwissTurn toolholders have a mechanism optimized for insert clamping and replacement on Swiss-type machines and JetCut high-pressure coolant tools.
For slot milling, chatter-free endmills maximize stock removal, eliminate vibration, and reduce cycle time.
PentaCut parting and grooving inserts perform cut-off operations. It’s a stronger insert for higher machining parameters on soft materials, parting of tubes, and small and thin-walled parts.
SwissCut tools are used in face and OD turning (screw head turning), while drilling is handled by SolidDrill with drilling depths of 3xD and 5xD.
Thread milling operations feature SolidThread, with short, three-tooth cutting zones with three flutes and released necks between the cutting zone and shank.
SolidMill solid carbide endmills with 2-flute, 30° helix medium length, perform key head milling operations.
Grades designed for machining applications on stainless steel and super alloys such as IC900, IC907, IC806, IC908, IC328, and IC928 are suited to milling and turning titanium and nickel-based alloys, such as Nitinol. These grades are available for Iscar standard tools with positive and sharp-edged chip formers.
ISOTurn turning tools support rough turning, performing most of the industry’s chip removal from finishing to roughing. For profile machining, intricate and precise V-Lock, V-shaped, special profile grooving inserts range from 10mm to 36mm. Precision ground and utility Cut-Grip full-radius inserts can perform semi-finish turning.
SumoCham drilling tools perform rough drilling, offering fast metal removal and economical indexing. A clamping system improves productivity and a shank with twisted nozzles delivers a stable body.
Chatter-free, 4-flute endmills perform semi-finish milling and feature 38° helix and variable pitch. ChamGroove internal grooving inserts, with 8mm, 11mm, and 15mm diameters, incorporate internal coolant for semi-finish grooving.
Semi-finish internal turning is handled by ISOTurn inserts with SwissTurn toolholders, while the cut-off operation uses Do-Grip twisted double-sided parting inserts that eliminate DOC limitations.
For rough turning, the SwissTurn ISO standard inserts small shank sizes support rough turning. Standard geometry inserts with precision ground cutting-edges and small radii are available.
Heli-Grip double-ended inserts perform rough internal turning, as the twisted design allows them to groove deeper than the insert length. Internal finish milling is handled by 3-flute, 30° helix, SolidMill endmills. Endmills with four flutes, 38° helix, and variable pitch for chatter dampening perform finish shouldering. A special-shaped endmill for upper and bottom chamfering operations follows drilling.
SolidDrill solid carbide drills perform drilling. A right-hand cut is available with and without internal coolant nozzles.
Thread milling, performed by SolidMill endmills, integrate coolant holes for ISO thread profiles. ISO standard inserts with SwissTurn toolholders featuring JetCut high pressure coolant support rough turning while Cut-Grip precision inserts perform external grooving.
Four-flute, 38° helix, variable pitch SolidMill endmills with 3xD relieved necks perform final milling.
Multi-Master endmills perform slotting, featuring no setup time, quick-change carbide-thread connections, and conical and face contact for high precision.
Spot milling is performed by 4-flute, 38° helix and variable pitch for chatter dampening, and 3xD relieved necks SolidMill endmills.
Multi-Master endmills with indexable solid carbide heads support slotting. Precision ground ISO standard geometry inserts used with SwissTurn toolholders featuring JetCut high-pressure coolant perform turning.
SolidMill 3-flute, 30° helix endmills are employed for profile milling, and 4-flute SolidMill endmills with chatter-dampening 38° helix and variable pitch with 3xD relieved necks perform face milling.
For rough milling, finished endmill geometries allow simultaneous roughing and finishing. Multi-Master interchangeable solid carbide tapered heads allow finish milling, where curved surfaces can be machined by tilting the tool and applying a large corner radius at small cutting depths. Shouldering, with chatter-free endmills with high material removal rates, eliminates vibration and reduces cycle time.
For final milling, use Multi-Master 4-flute, 30° helix short solid carbide ball-nose endmills. SolidDrill with 4xD drilling and no coolant holes provide stable, accurate drilling. SolidThread 55° or 60° profile thread mills handle mill threading.
Demand from multiple industries is driving metal 3D printing’s (3DP) continued strength and is accelerating growth in the 3DP filament market.
$800 million in 2018 24.7% CAGR to 2025 | Medical, accounts for considerable revenue share; expected to follow the automotive segment (26% CAGR) in terms of revenue growth; key driver – increasing adoption for manufacturing medical instruments
By having facilities closer to customers, Mahr can help them learn the range of inspection tools available.
Located in Wixom, Michigan, just west of Detroit, Mahr Inc.’s newest Midwest Regional Customer Center recently celebrated its grand opening. Mahr’s President, CEO, and VP of Sales, America, Brett Green offered some industry insight and thoughts on the company’s new facilities.
“These customer centers will play a key role as we continue to roll out a regional structure focusing on being local to our customers,” Green says.
4 Flute Carbide End Mill High Quality Supplier
With a portfolio of more than 16,000 products, not every Mahr device is relevant to every location. “We made a decision based on what each region looks like, along with its culture, in determining where to open customer service centers,” Green explains. “We have a facility in Erlanger, Kentucky, that has been open for about 10 years. There’s one in Cypress California. We recently opened one in Greenville, South Carolina, and with the addition of this location, we now have one that is close for our Canadian customers. In addition, we have a partner we are collaborating with for a facility in the Pacific Northwest.”
Advanced manufacturing industries have strict quality guidelines for everything. By having facilities closer to customers, Mahr can help them learn the range of inspection tools available.
“Some customers may only know Mahr instruments at the end of the production line in a controlled environment such as an inspection room,” Green notes. “Connecting with customers in regional facilities enables us to educate them about what’s available and find the right approach for their production process.”
Carbide Drill Bits, Carbide End Mill, Carbide Reamers - Millcraft,http://www.millcraftools.com/