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UKCA: UK’s Proposed ‘CE Mark’ Replacement

In February 2019, the MHRA published guidance on the use of the ‘UKCA’ (UK Conformity Assessed) mark in the event of a ‘No-Deal’ Brexit. The guidance stated that the UKCA mark would not be recognised on the EU market and manufacturers would still be required to obtain CE marking for products to be placed on the EU market and that the UKCA mark will need to be applied in the following situation(s);

  • The product is for the UK market.
  • The product requires mandatory third-party conformity assessment.
  • The conformity assessment for the product has been carried out by a UK conformity assessment body (a UK-based notified body or recognised third-party organisations).

The guidance also stipulates that “in the majority of cases you will still be able to use the CE marking if you are selling goods on the UK market after the UK leaves the EU. The CE marking will only be accepted in the UK for a limited time after Brexit”, however, this guidance was withdrawn on 30th January 2020.

With the deadline for the end of the 1-year transition period fast approaching, it is still unclear whether the UK government intends to put these measures in place. As a result, manufacturers are urging the UK government to provide more details and guidance on these plans to ensure they have adequate time to prepare to affix the UKCA mark on their products.

It is understood that the UK government is not likely to announce details of the new UKCA mark until a mutual decision has been made as part of the ongoing UK-EU trade negotiations. Understandably, concerns are growing as to the relatively short time left to put any new UK requirements in place to ensure compliance before the end of the year, although we have been made aware from a reliable source that the MHRA is currently reviewing the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

We will keep you posted with any updates as soon as we receive them.

Intended Use VS Indications For Use

Over the years, the amount of regulatory terminology seems to grow at a constant rate, and so it is no surprise that even the more fundamental terms start getting confused. We have seen many cases in which “Intended Use” and “Indications for Use” have been used interchangeably. Sometimes, “Indications for Use” are not even considered! So why does it matter?

The “intended use” of a device is critical for determining its classification, and is usually defined during the initial regulatory stages. However, the “intended use” is often misunderstood. Its purpose is not to describe what the device is intended to be used for. Instead, it should lay out the claims of what your device is meant to do. This is precisely why the classification will be based on the intended use, that is, on the manufacturer’s claims. It is good practice to keep the intended use statement concise, as long as it details all the fundamental claims appropriately.

On the other hand, the “indications for use” will lay out the conditions in which the user would use the device, that is, the reason or situation for use.

If you have any further questions, please let us know!

Medical Device Regulation: Technical File Requirements

There is a concern that many manufacturers who CE mark class I medical devices do not have adequate technical (safety) data to provide in the event of a European complaint, regulatory or vigilance enquiry. The fact that class I devices are “self-certified” does not absolve the manufacturer from having sufficient technical and safety data to support their marketing activities in the EU.

In addition, as from mid-year (probably May / June), anyone who exports medical devices into the EU may have to assure that their importer, and authorised representative (such as ourselves), has suitable access to the company technical documentation to demonstrate conformity to the regulations. So, in that respect, importers and authorised representatives could be asked to show how they can gain access to device technical files in a timely manner. To not be able to do this could mean exposure to legal issues and, in particular product liability claims, as all economic operators could be held liable to assure device conformity.

We strongly urge these processes to be considered as soon as possible before the new EU regulations are upon you;

  1. Assure you have up-to-date, signed and approved regulatory files that are reviewed for completeness. Such files should concentrate on safety (by risk management) and a demonstration of conformity to the EU “Essential Requirements” (Now called “General Safety and Performance Requirements” in the Regulations) by using a check list. All manufacturers selling in the EU must have a suitable “Declaration of Conformity”. If you are an Advena Ltd. Authorised Representative client you will know we insist on the latter before we will contract with you.
  2. Assure that your importers (that is the businesses who first bring your devices into the EU – you may have several) understand their responsibilities for being able to access your technical data.

NOTE:    Having access to technical files does not mean the economic operator having the information physically on file in their premises, although this may be the way you want to work.  As most technical file documents are live, and subject to continual improvement and update, this information could be on a cloud server with permission to be being given in the event of a regulatory enquiry. However, Authorised Representatives must be able to show they have verified that the text is available and complete.

Any Non-EU medical devices manufacturers seeking an EU Authorised Representative (EC REP) should contact Advena Limited by email: info@advenmedical.com to request detailed information about our services and a quotation.

Advena Ltd will be represented at ExpoMedical 2016 in Argentina

logoexpoThanks to our new trusted partners in Argentina we are being represented at ExpoMedical medical device trade show in Argentina. This show is at the Centro Costa Salguero; Av. Costanera R. Obligado y J. Salguero Buenos Aires Argentina and runs from the 28th to 30th September.

Advena Ltd will be represented at Booth # 5 – A19 of MMG Consulting SRL Medical Devices / Regulatory Affairs, contact magdalena.delsel@mmgc.com.ar https://www.mmgc.com.ar

EN ISO 62304: 2006 Medical Device Software Validation

The topic of software validation is one that continues to cause confusion, so we have developed a series of flowcharts to help clarify the requirements. These cover:

* EN ISO 62304; 2006 medical device software – software life cycle processes
* FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Please contact Farhaan Shaikh on +44 (0)1926 800153 or via email to farhaan.shaikh@advenamedical.com for further information.

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