Combating corona: European standards for medical supplies made freely available

Combating corona: European standards for medical supplies made freely available

European Union bureaucrats have stepped up to the plate and to provide a small but significant contribution to combat Covid-19. The combat against the spread of the Corona-virus is challenging due the great shortage of face masks and other personal protective equipment for medical staff. In an effort to help increase the availability of masks, gowns and gloves the European regulators and standardizers try to remove any obstacle to increase production by making the European harmonised standards available to producers free of charge.

Upon the urgent request of the Commission, the European standards bodies CEN and CENELEC, in collaboration with all their members, have agreed to immediately make available a number of European standards for certain medical devices and personal protective equipment. This action will help both EU and third-country companies willing to manufacture these items to swiftly start production and place products on the internal market more easily while ensuring a high degree of safety.

The agreement has immediate effect. The 11 standards developed by CEN and potentially 3 additional ones developed jointly with ISO that are made available cover common filtering masks, medical gloves and protective clothing.

Eye contact.
Photographer: Ani Kolleshi | Source: Unsplash

How the free access to these standards helps increasing production

Providing free access to the national adoptions of these European standards helps both EU and third-country companies which are reconverting their production lines to manufacture quickly these critical items for preventing the coronavirus pandemic. The use of the standards will enable companies that use them to access the market for such fundamental medical and protection equipment quicker and to provide those in need with such medical equipment.

Normally, standards must be purchased and used in line with the intellectual property right rules. The copyright of the standards lies with the organisations, which have developed the standards. The derogation from this business model is a strong European response to address the shortage problem of protective equipment deriving from the Covid-19 epidemics.

The standards are available for free download from the websites of CEN national members.

List of available standards:

In addition, possibly:

Medical device makers are on a recruitment drive as strict new EU rules edge closer

MEDICAL DEVICE MAKERS based in Ireland are ramping up their recruitment measures to meet stringent new EU regulations that are just months away.

US manufacturer Cook Medical is hiring 20 new full-time roles in its Limerick base, which is largely responsible for compliance with the EU’s Medical Device Regulation (MDR).

“These roles are part of a larger recruitment drive globally, specific to the EU MDR,” Sinead Burke, director of regulatory affairs at Cook Medical Europe, told Fora. “We have also taken on over 70 new contract roles globally to help with the implementation of EU MDR.”

The MDR is a set of new rules passed by European lawmakers in 2017 that will introduce much stricter clinical reporting and post-market surveillance responsibilities for device makers.

Recruitment at Cook Medical is mostly around roles in regulatory affairs and engineering to meet this new system.

Burke explained that “key changes within the regulations required us to invest in these new roles” to put more emphasis on clinical and post-market clinical follow up procedures.

She said the regulation change will have a “big impact” on all six of Cook Medical’s manufacturing sites worldwide.

“(It) will integrally change the way we work in a lot of key areas of our business, but we are fully committed to making sure we are compliant and embrace this new legislation as a positive step.”

Medical device giant Stryker is also carrying out a similar strategy. The firm, which employs more than 3,500 people in Ireland, is recruiting engineers and project managers at its Cork plant specifically for MDR work.

Medtronic, the world’s largest medical device maker that is formally headquartered in Dublin, declined to comment on its recruitment efforts, but a spokesperson said it has “created a comprehensive implementation plan to transition our products to the new regulation”.

The company has a number of people working on compliance vigilance in its Ireland operations.

Preparedness

While medical device makers are making strides in being compliant, there are still many areas of the system that are concerning the industry, particularly in relation to notified bodies, organisations that are designated by the European Commission to certify devices for the market.

While the legislation was passed in 2017, only seven notified bodies have been approved. There are dozens across the European market.

This slow pace has led to fears of limited resources to meet the rush to get devices checked by May 2020 to avoid any shortages of products.

Cook Medical’s Burke said that the company has been advocating a more streamlined approach to the notified bodies system.

“The timeline set out within the regulation at the notified bodies means to date (seven) notified bodies have been designated with only seven months before date of application,” she said.

“There are much fewer notified bodies than previously, with some recent fallout and an increase workload on notified bodies, which makes for a worrying trend.”

Source: Jonathan Keane of Fora.

UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup

The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit. Full details of the Medicines and Medical Devices Bill are yet to emerge, but the government sketched out the main benefits and elements in a briefing document this week.

The overarching goals of the plan are to put the UK at the forefront of the life sciences industry, thereby cutting the time it takes for patients to access medicines and to give it a leading role in efforts to cure rare diseases. To achieve those goals, the government plans to “remove unnecessary bureaucracy for the lowest risk clinical trials, encouraging the rapid introduction of new medicines.” The outgoing EU clinical trial rules were criticized in some quarters for imposing excessive burdens on small, low-risk studies. The planned loosening of the UK rules is part of a push to make it easier for hospitals to trial and make medicines and diagnostics devices.

The government also wants to use the legislation to drive the Medicines and Healthcare products Regulatory Agency (MHRA) to develop regulations to help companies “break new ground in complex clinical trials.” Other plans discussed in the briefing document include the implementation of a scheme to stop fake drugs from entering the supply chain, plans to register online retailers and the creation of a framework that supports the updating of legislation. The government wants the ability to update legislation on all aspects of life sciences in response to patient safety issues and changes to the UK’s future global relationships.

The government presented details of the planned bill as part of the Queen’s Speech, which is used to set out the legislative agenda for the upcoming parliament. On this occasion, the Queen’s Speech took place in an unusual context that means it is questionable whether any of the proposed texts will be debated and passed. As it stands, the government lacks a majority to pass legislation, meaning it would need to rely on the support of opposition parties to bring the Medicines and Medical Devices Bill into law. The likelihood of the current parliament passing the law is further diminished by the fact that observers expect a general election either this year or in 2020. If the government wins the election, it may then make the Medicines and Medical Devices Bill part of its legislative agenda for the next parliament.

Source: RAPS Link

UK Government Brexit Guide Clarifies Rules for Manufacturers

On 8 October the UK Government issued its “No Deal Readiness Report”. Whilst it is not yet known whether the UK will leave with or without a Withdrawal Agreement at the end of October, the report sets out guidance for industry across a range of sectors – including providers of medicines and medical devices.

Guidance can be found via the link here. Please see page 78 and further for the guidance on the various legislation per industry sector.

In summary, if there is no deal:

The UK would manage its own set of regulations on manufactured goods separate from the EU if we leave without a deal, and UK businesses exporting to the EU would need to meet EU rules.

Many manufactured goods sectors, such as chemicals, aerospace goods, human and veterinary medicines, medical devices and automotive vehicles, are subject to common rules across the EU. These rules establish common requirements for manufacturing, testing and marketing products from these sectors. Currently, it is a legal requirement to follow these rules before selling regulated products in the EU.

Having separate regulatory regimes for manufactured goods will mean that:

  • The UK will be able to set its own regulations that the businesses in the EU and other countries will have to follow before selling products on the UK market. This means that the UK could set regulations for imports into the UK rather than having to follow EU regulations.
  • UK businesses exporting to the EU will need to make sure they meet EU rules. This includes, where relevant, having goods approved by EU-based bodies or having legal representatives in the EU.
  • Approvals and authorisations on goods issued by UK bodies will not be accepted in the EU, even where these meet EU regulations or were issued by a UK body while the UK was still an EU member state. However, there are some exceptions to this if the EU has made a short-term commitment to accept goods.
  • The UK will no longer be part of any ongoing EU agency or regulator activities. For human and veterinary medicines, chemicals and aerospace products, the relevant EU agencies which play a role in regulating goods are the European Medicines Agency (EMA), the European Chemicals Agency (ECHA) and the European Aviation Safety Agency (EASA) respectively. UK regulatory bodies will no longer be able to license products for the EU market and the UK will no longer participate in relevant committees.
  • UK regulators will take on regulatory functions currently carried out by EU regulatory bodies.

The UK Government’s preparations for leaving without a deal:

  • The Government has introduced new regulations to accept goods made against EU rules (including goods subject to assessments made by EU conformity assessment bodies) in the UK. This will mean that goods with the CE mark (which also include toys, electronics and machinery) can still be sold in the UK.
  • The Government will provide continuity in goods regulation for a temporary period after exit day in order to provide as much stability as possible for businesses immediately following the UK leaving without a deal.
  • For the automotive, chemicals and medicines sectors the UK is putting in place light-touch processes to allow businesses to convert existing EU approvals into UK approvals.
  • The UK Government will introduce a new UK regulatory framework for CE-marked goods that will allow manufacturers to show that products meet UK rules and can be sold in the UK. This will include introducing a UK-only mark -called the UKCA mark -and a system of UK Approved Bodies. The UK Government published advice on using the UKCAmark.
  • The CE mark will be retained for medical devices to ensure continued access for UK patients. Section B sets out the UK Government’s preparation for the regulation of medical devices.
  • The UK Government has published technical notices on placing manufactured goods on the UK and EU markets after Brexit, as well as on what has changed across the product safety and legal metrology regimes, and consumer rights. There is dedicated, tailored advice available for the chemicals, medicines, veterinary medicines, construction, aerospace, rail and automotive sectors.

The UK Government has intensified preparations since 24 July 2019 on the following topic:

  • The UK Government is preparing a new public database of conformity assessment bodies who will be able to assess products against UK rules before they are UKCA-marked.
  • The UK Government will engage with industry before making any changes to regulatory arrangements, and, in the event of any changes, the UK Government is committed to giving sufficient notice of any change. The UK Government will give two years’ notice of any changes to regulations for medical devices.
  • The UK Government has refreshed the information in all of the aforementioned technical notices with up-to-date advice for businesses.

What Brexit Means For Businesses:

All businesses who manufacture, trade or distribute manufactured goods should take action.

All businesses who manufacture, trade or distribute manufactured goods should take the following actions:

  • Check all relevant guidance available on GOV.UK and pay close attention to the UK Government’s Brexit communications campaign for more details on the actions required to prepare if we leave without a deal.
  • Check whether they need new product approvals, whether they need to appoint new representatives in the EU, make changes to the labels and markings on their goods, or submit information to new UK systems.
  • Check what actions they or their suppliers need to take in relation to the manufacture and import of chemicals so that they continue to receive necessary ‘input’ goods. These actions are listed below.

Manufacturers of goods currently regulated under the EU’s ‘new approach’ (i.e. mostly CE-marked goods) should take the following specific actions:

  • Businesses exporting CE-marked goods should check whether their goods are supplied in the EU via an EU-based distributor. If so, that distributor will become an importer. UK distributors of CE-marked goods from the EU will also become importers. Importers have certain legal responsibilities, including making sure products are accompanied by their address.
  • Where businesses are required under EU law to get third party approval of their goods, they should confirm whether current approvals are issued by a UK or EU-based notified body. If unsure, the business will need to check with its notified body as in some cases, they may be making arrangements on businesses’ behalf. If the business uses a UK notified body but plans to continue to export CE-marked goods to the EU, further arrangements should be made to have the products approved by an EU recognised notified body. To do this, the business can either get the products reassessed by an EU recognised notified body or arrange for the files to be transferred to an EU notified body before the UK leaves the EU.
  • If the business only sells to the UK market and uses a UK-based notified body, action should now be taken to be ready to use the UKCA mark.
  • For medical devices, there will be no UKCA marking so all devices sold in the UK will continue to require the CE marking (see below for details).
  • Businesses who currently use an Authorised Representative to act on their behalf should confirm where their Authorised Representative is located. EU-based Authorised Representatives who received their mandate before 31 October 2019 will still be recognised in the UK after 31 October 2019. However, a UK-based Authorised Representative will not be recognised in the EU as able to fulfil this role after 31 October 2019.
  • UK businesses who export machinery to the EU will need to make sure they have nominated a person authorised to compile technical files who is based in theEU. This person could also be an importer or Authorised Representative.
  • Where businesses have made any changes to how their product is approved or marked, or if there is a new importer or Authorised Representative, they should draw up a revised declaration of conformity with the correct details. Where the CE marking is used, this should still be an EU declaration of conformity. If the UKCA marking is used, then it will need to be a UK declaration of conformity.
  • Businesses that self-certify compliance withEU law and place the CE marking on the product can continue to do so.

ATEX Directive: New List of European Harmonised Standards Published

ATEX Directive - New List of Harmonised Standards

On the October, 2018, the European Commission published a new list of European harmonised standards for the ATEX Directive (2014/34/EU)

If the ATEX Directive applies to your products, we recommend you to check if the standards you or your suppliers have used have been amended, or that new relevant standards have been included in the list.

The following standards have been added to the list for the Low Voltage Directive:

EN 17077:2018 – Determination of burning behaviour of dust layers
EN ISO/IEC 80079-38:2016 – Explosive atmospheres — Part 38: Equipment and components in explosive atmospheres in underground mines (ISO/IEC 80079-38:2016)
EN ISO/IEC 80079-38:2016/A1:2018
EN 50271:2018 – Electrical apparatus for the detection and measurement of combustible gases, toxic gases or oxygen — Requirements and tests for apparatus using software and/or digital technologies

The PDF documents with the new lists of standards have been added to the CE Marking Library of our online platform already. The new and amended standards are being included in the standards database.

If you have questions, please let us know.

EN 12312-6 Superseded

CE Marking Directives, Regulations and Standards

On 30 September 2017, the EN 12312-6:2014 + A1:2009 for Aircraft ground support equipment – Specific requirements – Part 6: De-icers and de-icing/anti-icing equipment was supeseded by the version EN 12312-6:2017. The superseded version may not be used as proof of conformity with the Machinery Directive (2006/42/EC).