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Which Countries Require CE Marking of Medical Devices?

 

28 Member States 2013 Which Countries Require CE Marking of Medical Devices?

This blog serves as a reference guide with a discussion of, information resources for, and list of which countries require CE marking of medical devices.

You can locate the current list of countries that require CE Marking of medical devices by visiting the list of Competent Authorities (CAs) on the following Europa webpage (http://bit.ly/ContactPoints). That page has 33 national CAs identified. CAs are the US FDA equivalent in the European Union (EU). In addition to member states in the EU, the CAs list also includes signatories (i.e., – countries that have signed the 1985 Schengen Agreement to allow people to pass between countries with no border controls) and EU candidate member states. For the most current status of candidate member states and potential candidate member states, you can visit the following Europa webpage: (http://bit.ly/EuropaCountries). As of September 21, 2013, the status of the 33 CAs are categorized in the list at the end of this blog posting.

Australia-EU Mutual Recognition Agreement

In addition to the 33 countries listed below, the Australia Therapeutics Goods Administration (TGA) has a mutual recognition agreement with the EU—the EC MRA (http://bit.ly/TGA-EU-MRA). This agreement, however, has limitations. The agreement includes a rule of origin clause which excludes products manufactured outside the EU and Australia. Other restrictions include:

  • Radioactive medical devices
  • High-Risk, Class III devices
  • Excluded barrier contraceptives, including condoms
  • Devices, including medicinal and those of biological origin
Kingdom of Saudi Arabia

In the Kingdom of Saudi Arabia (KSA), you can begin the medical device registration process if your company has regulatory approval from one of the founding members of the Global Harmonization Task Force (GHTF). The five founding members are: 1) USA, requiring a 510(k) or PMA; 2) Canada, requiring a Medical Device License; 3) Europe, requiring CE Marking; 4) Australia, requiring Australian Register of Therapeutic Goods (ARTG); and 5) Japan, requiring Japanese Pharmaceutical Affairs Law (JPAL) certification or approval. The next step is to select an Authorized Representative in the KSA and submit a Medical Device Marketing Authorization (MDMA) application. For low and medium risk device classifications (i.e., – Class I, IIa and IIb), you may begin marketing your device in the KSA prior to obtaining formal regulatory approval (this regulation is subject to potential change). For higher risk devices (i.e., – Class III), you must first obtain MDMA certification prior to distribution of the device in the KSA. The medical device regulations for the KSA are interim regulations. You can verify the current regulations by visiting the Saudi Food and Drug Authority (SFDA) website (http://bit.ly/SFDAMedicalDevices).

Other Countries

Many other countries have alternate abbreviated processes similar to Australia and the KSA if your medical device is already approved by one of the GHTF countries. Often, this is stated as “country of origin approval.” Countries recognizing country of origin approval that offer an abbreviated approval process include: Argentina, Singapore, China, etc. These countries do not simply “rubber stamp” the approval, but the approval process is less rigorous.

If your product is manufactured in the U.S., but you do not have a PMA or 510(k) issued by the US FDA, a CE certificate is not enough. Your company must establish country of origin status in Europe to take advantage of the abbreviated approval processes. This is sometimes done by establishing a facility in Europe, but the CE certificate must be issued to the European facility. Other workarounds have been developed, but that is beyond the scope of this blog.

2 EU Candidate Member States with Competent Authorities

These two countries below are candidate member states for joining the EU. These countries are not signatories, but both countries have established a competent authority for reporting recalls and vigilance related to medical devices distributed within their borders. Turkey has also has established four Notified Bodies.

  1. Iceland
  2. Turkey

3 EEA Signatories with Competent Authorities

For a long time, Switzerland was neither a member of the EU, nor a signatory. However, in 2008, Switzerland became the 25th country to sign the Schengen Agreement which allows people to pass between countries with no border controls. All three countries below have established a competent authority. Switzerland has established five Notified Bodies, and Norway has two.

  1. Liechtenstein
  2. Norway
  3. Switzerland

28 EU Member States with Competent Authorities

The list below identifies the 28 members of the EU. The date in parenthesis is the year that each member joined the EU. All of these countries have competent authorities that regulate medical devices, and many of these countries have established Notified Bodies. Germany, Italy and the UK have the greatest number of Notified Bodies.

  1. Austria (1995)
  2. Belgium (1952)
  3. Bulgaria (2007)
  4. Croatia (2013)
  5. Cyprus (2004)
  6. Czech Republic (2004)
  7. Denmark (1973)
  8. Estonia (2004)
  9. Finland (1995)
  10. France (1952)
  11. Germany (1952)
  12. Greece (1981)
  13. Hungary (2004)
  14. Ireland (1973)
  15. Italy (1952)
  16. Latvia (2004)
  17. Lithuania (2004)
  18. Luxembourg (1952)
  19. Malta (2004)
  20. Netherlands (1952)
  21. Poland (2004)
  22. Portugal (1986)
  23. Romania (2007)
  24. Slovakia (2004)
  25. Slovenia (2004)
  26. Spain (1986)
  27. Sweden (1995)
  28. United Kingdom (1973)

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EU Medical Device Directive: 6 New Essential Requirements

%name EU Medical Device Directive: 6 New Essential RequirementsEssential Requirements (ER) changes  in the proposed EU Medical Device Regulations versus the ER in Annex I of the EU Medical Device Directive are reviewed.

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Annex I of the European Medical Device Directive (http://bit.ly/M5MDD) is titled “Essential Requirements.” Most companies demonstrate that their device meets the 13 Essential Requirements (ERs) by creating an Essential Requirements Checklist (ERC). I have no idea what the origin of the ERC is, but you know that regulators love tables and checklists. This particular checklist is so commonly used that the Global Harmonization Task Force (GHTF) included an example of an ERC, called an “Essential Principles Checklist” (EPC) at the end of a guidance document on how to create Summary Technical Documentation (STED) for In Vitro Diagnostic devices (http://bit.ly/STEDIVD)—which is now maintained on the IMDRF.org website.

On September 26, 2012, the European Commission released a proposal for new EU Medical Device Regulations (http://bit.ly/EUProposal). This proposal still includes ERs in Annex I, but there are 19 ERs in the proposal. One regulatory professional recently sent me a follow-up question in response to an audio seminar I conducted in November (). Her question was, “What are the six new ERs?”

A few of the early reviews of the proposal indicated that there were no significant changes, but I have learned the hard way that you should always go to the source and verify the information for yourself (i.e., – Genchi Genbutsu). Here’s what I found:

General Requirements (ER 1-6a)

  1. No real change to this requirement.
  2. This requirement was reworded to clarify the intent (see Annex ZA of EN 14971:2012 for more info @ http://bit.ly/ISO14971-2012changes).
  3. It appears as though the Commission thought the current ER 3 was redundant, and the requirement was addressed by ER 1 and ER 5 already.
  4. This is now the new ER 3, and the requirement now clarifies how Notified Bodies shall apply this requirement in cases where a lifetime of the device is not stated.
  5. This is now the new ER 4, and there is no real change.
  6. This is now the new ER 5, and the wording has been clarified.

ER6a is conspicuously missing from the proposed ERs, but don’t get excited. Clinical evaluations are still required as part of the Technical Documentation in Annex II, Section 6.1c: “the report on the clinical evaluation in accordance with Article 49(5) and Part A of Annex XIII.”

Chemical, Physical & Biological Properties (ER 7)

ER 7.1 has one new requirement: “d) the choice of materials used, reflecting, where appropriate, matters such as hardness, wear and fatigue strength.” ER 7.2 and 7.3 remain unchanged. ER 7.4 has been simplified to what is proposed as the new, shorter ER 9. ER 7.5 is now the new ER 7.4, and the changes reflect the current status of phthalate regulations and similar issues. ER 7.6 is now the new ER 7.5, but there is no change to the content. The new ER 7.6 requires that manufacturers address risks associated with the size and properties of particles—especially nanomaterials. The changes associated with this section will impact certain device types more than others—such as orthopedic implants.

Infection & Microbial Contamination (ER 8)

ER 8 is still ER 8, but ER 8.1 is now prescriptive regarding design solutions, and the current ER 8.2 is now the new ER 10. The new ER 10 is expanded and references the new EU regulations regarding devices manufactured utilizing tissues or cells of animal origin: Commission Regulation (EU) No 722/2012 of 8 August 2012 (http://bit.ly/AnimalTissueReg). The new ER 8.2 is a new requirement that was an oversight of the MDD, and the new ER 8.7 now clarifies that the labeling must differentiate sterile and non-sterile versions of the product; packaging is no longer an acceptable mechanism for differentiation. The balance of ER 8 remains unchanged.

Construction & Environmental Properties (ER 9)

This ER is now identified as the new ER 11, and this section is expanded. This reflects the emphasis on the need to evaluate the safety of devices with accessories, compatibility with other devices, and the effects of the use environment.

Devices with a Measuring Function (ER 10)

This ER is now identified as the new ER 12, but ER 10.2 from the current Directive appears to be missing. What’s up?

Take a look at the new ER 11. ER 10.2 is now the new ER 11.6.

Protection Against Radiation (ER 11)

This ER is now identified as the new ER 13, but there is nothing new.

Requirements for Devices Connected to or Equipped with an Energy Source (ER 12)

ER 12.1 and 12.1a are now ER 14. This section is specific to software requirements and has more detail than the current Directive. IEC 62304:2006, “Medical device software – Software life cycle processes,” is the Standard that will be expected by Notified Bodies as a reference for ER 14. ER 12.2 through ER 12.6 are now ER 15, but there is nothing new. Section ER 12.7 and its sub-parts are now addressed by ER 16. ER 12.8 and its subparts are now addressed by ER 17.

Information Supplied by the Manufacturer (ER 13)

This is now identified as ER 19: “Label and Instructions for Use.” This section is simplified from ER 13 (i.e., – there are fewer sections), but this ER does not seem to be any shorter. ER 19.1 has subparts a-g, and this ER section incorporates the concepts previously addressed by ER 13.1, 13.2, 13.4 and 13.5. ER 19.2 is a new and improved version of the previous ER 13.3 specific to labeling requirements. This labeling section is expanded from subparts “a” through “n” to “a” through “q.” The UDI requirement is subpart “h”. ER 13.6 is now ER 19.3 specific to the Instructions For Use (IFU). This section is expanded from subparts “a” through “q” to “a” through “t.”

The number of subparts to ER 19.3 doesn’t reflect the additional requirements for IFUs that are proposed by the Commission. The subsections of this part warrant special attention. Items that frequently are found missing from IFUs on the market today include:

  1. ER 19.3c – performance intended by the manufacturer
  2. ER 19.3h – installation and calibration instructions
  3. ER 19.3k – how to determine if a reusable device should be repaired/replaced
  4. ER 19.3m – restrictions on combinations with other devices
  5. ER 19.3o – detailed warning information
  6. ER 19.3p – information about safe disposal of the device
  7. ER 19.3t – notice to user/patient to report adverse events

ER 18 – Use by Lay Persons

This is a short section, but the requirement is new. There are now additional requirements for products intended for use by a lay person. The risk management report, design validation, and clinical evaluation report will need to include specific evidence to demonstrate conformity with this ER. The post-market surveillance plan for these products should carefully verify the accuracy of risk estimates. Post-Market Clinical Follow-up (PMCF) studies would be challenging in the past, but the prevalence of social media and product registration databases may facilitate conducting PMCF studies for these products in the future.

Australia & Canada

There is also an EPC that is required by the Therapeutic Goods Administration (TGA) in Australia, (http://bit.ly/EPCTGA) and  Therapeutics Product Directorate (TPD) in Canada (http://bit.ly/CanadianSTED). If you would like to learn more about the Essential Principles of Safety and Performance, you should also review the GHTF guidance document on this topic (http://bit.ly/EPSafetyPerf) on the IMDRF.org website. This 2012 version of the document supersedes GHTF/SG1/N041:2005.

I have observed approval of products where the European ERC was submitted in lieu of an EPC for Australia and Canada. I guess they are a little more rational than some other regulators, but if you have experienced any “push back” regarding this approach please share this by posting a comment or by sending an email.

If you need assistance with medical device CE Marking, or you are interested in training on CE Marking, please contact Medical Device Academy at: rob@13485cert.com. Medical Device Academy is developing a webinar series specifically for this purpose. You can also call me by phone @ +1.802.258.1881. For other blogs on the topic of “CE Marking”, please view the following blog category page: http://robertpackard.wpengine.com/category/ce-marking/.

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What is a MEDDEV?

The author defines what a MEDDEV is, recent updates and information resources to learn more.

The most important part of my website is the “Helpful Links.”  These are the links that I use most in Regulatory Affairs. It started as an auditor’s toolbox, but now I am morphing it into a place to review updates to regulatory requirements and external standards. The MEDDEV’s are on the top of my list. These are the guidance documents written by Competent Authorities, but most of the Notified Bodies treat them as requirements, and often write nonconformities against at least one of them: MEDDEV 2.12/1 – Medical Device Vigilance System.

Many companies rely on RSS feeds to keep them current on the latest external standards, but this doesn’t work for a MEDDEV. For MEDDEV’s, your best bet is to go to the source. Sure, you can hire a consultant that will try and keep you current. You can also wait until your NB auditor lets you know the hard way (i.e,. – time to write another administrative CAPA).

For those of you who don’t know the source, it is my #1 “Helpful Link”:

http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

When asked how to keep current, my advice is to have a systematic process for checking various sources of external documents. At a minimum, you should be checking all of the possible sources just prior to each Management Review. This will give you something to include for the requirement in clause 5.6.2h) of the ISO 13485:2003 Standard. “More preferably,” as lawyers would say, check out the website link above at least once per month. For those of you that are completely out of touch, and those that just fell off the University hay ride, the following explains why you can’t get away with saying:

“There haven’t been any new or revised regulatory requirements since the last Management Review.”

MEDDEV Updates

There were several updates to the MEDDEVs released as supporting documents for the M5 version of the MDD (93/42/EEC as modified by 2007/47/EC). Specifically, there were four in December, 2009 and one in June, 2010. Then there were two more MEDDEVs released in December, 2010 related to clinical study requirements in Europe. In January, 2012, another six MEDDEVs were released, and one more was released in March. Not all of these updates apply to every company, but every RA professional working on CE Marked products has been busy reading themselves to sleep at night.

I could spend some time here telling you a couple of sentences about each of these new MEDDEVs, but someone already did that for me:

http://www.eisnersafety.com/eu-medical-device-meddevs-guidance-docs-newly-rlsed-or-updated/#.T8Oml7Dy-So

One fellow blogger indicated that the MEDDEV 2.5/10, about Authorized Representatives (ARs), was disruptive:

http://medicaldeviceslegal.com/2012/02/09/new-meddev-on-authorised-representatives-everything-you-know-is-wrong/

I don’t really agree with Erik Vollebregt about it being disruptive. Erik feels that we can all expect substantial revisions in the AR contracts, but I think the Germany AR’s I have worked with were already moving in this direction. Emergo has been a strong AR all along—with a distinctly more friendly Dutch style to their processes. In the end, I just don’t see Notified Bodies (NBs) making these contracts a priority initiative. I think we’ll see more auditors verifying that contracts are in place and current, but I don’t expect auditors to receive guidance on how to review contracts anytime soon.

The real changes will be in the smaller AR’s that are not European Association of Authorized Representatives (EAAR) members. The Competent Authorities (CAs) have been knocking on the door of various “wanabee” AR’s for a few years now. I think they have done a nice job of shutting down illegitimate representatives, and the member companies of EAAR (http://www.eaarmed.org/) have done well in raising awareness. The next logical step was to provide some guidance, so that there is more consistency among the ARs. I see this as just the beginning of the CA’s moving toward one approach.

Another article was written by Erik about MEDDEV 2.12/2 on the subject of Post-Market Clinical Follow-up (PMCF):

http://medicaldeviceslegal.com/2012/01/17/new-eu-guidance-on-post-market-clinical-follow-up-studies-published-and-other-meddev-guidance-announced/

Erik just touched on this MEDDEV briefly, but if your company is a manufacturer of a Class III device that is CE Marked—YOU NEED TO READ THIS MEDDEV!

MEDDEV Whitepaper

As in all things post-market related, BSI has taken the lead by publishing an article that is almost as long as the original MEDDEV. This white paper was written by Dr. Hamish Forster, BSI’s Orthopedic & Dental Product Expert, and the document is called “The Post-Market Priority.” I think you can only obtain a copy of this white paper by requesting it from BSI online, but the customer service person that follows up is quite polite.

BSI’s leadership role in PMCF is not new either. Gert Bos gave a presentation that highlighted the importance of PMCF back on March 31, 2010:

http://www.bsigroup.nl/upload/Presentatie%2031%20maart%20-%20Gert%20Bos.pdf

My advice for anyone that has a Class III device that is CE Marked is to read this MEDDEV a few times, Annex X 1.1c of the MDD, read the whitepaper and review these presentations by Gert Bos. This will help you prepare for what is coming. For those of you that think you know something about PMCF, and have justified why your company doesn’t need to do it, think again. You should review the 16 bullet points in the MEDDEV on page 14 and 15 (17 bullets in the whitepaper, but one was just split into two parts). Identify how many of these points apply to your Class III device. The more points that apply to your product, the more extensive the NB’s will expect your PMCF plans to be.

 

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