The PPE crisis in the Post COVID era has made the provision of rigorous regulatory and quality management reviews and product certifications for medical device manufacturers — around the world a very important field of review for lawyers. The modern healthcare lawyer or for that matter any lawyer working on an international PPE contract must know the ins and outs of an SGS Report and a quality notified body CE certificate.
The Post COVID PPE procurement market saw CE certificates becoming a key focus, and what CE certificate was valid or not valid became a hot debate.Obviously this article could have made much more sense back in April and March 2020, when the confusion was driving procurement teams literally crazy, but then again our legal teams were a part and parcel of living through that confusion.
The challenges Asian medical device manufacturers face in today’s highly competitive post COVID marketplace make it essential that they should take quality legal advice on getting proper CE Certificate from a notified body,so their product meets all regulatory and quality requirements before launch. It is critical to work with a leader who understands the industry and has the experience to review and confirm the products’ readiness for market – efficiently, reliably and promptly.
This article is not to be considered as providing any legal advice and is not to be used as a substitute to getting proper legal advice from our team on the relevant legislation directly on how PPE health and safety regulations work around the world.
Common Questions!
What is CE marking and a Notified Body?
Where does the CE mark apply?
What is the role of the Competent Authority?
What is the role of the Notified Body?
How many Notified Bodies are there for the CE mark?
How many Medical Devices Directives and Regulations are there?
Who decided on the content of the new Regulations?
What is the process a manufacturer has to go through to get a CE mark?
What does a Notified Body have to review as part of the assessment process?
Does a Notified Body have to see the product as part of the certification process?
CE marking is the medical device manufacturer’s claim that a product meets the requirements of all relevant European Directives and Regulations and is a legal requirement to place a device on the market in the European Union.
The three Medical Devices Directives are:
- Medical Devices Directive(MDD)
- Active Implantable Medical Devices Directive (AIMDD)
- In-Vitro Diagnostics Directive(IVDD)
The Directives have been replaced by the Medical Devices and IVD Regulations on 26 May 2020 and then again there will be a change on 26 May 2022, respectively (depending upon how Brexit goes).There are a number of other related Directives and Regulations that might need to be considered for example, Regulation 722/2012 concerning devices manufactured utilizing tissues of animal origin.
EU Directives lay down certain end results that must be achieved in every Member State. National authorities have to adapt their laws to meet these goals, but are free to decide how to do so. Regulations are the most direct form of EU law- as soon as they are passed, they have binding legal force throughout every Member State, on a par with national laws.
Where does the CE mark apply?
The CE mark* is applicable in the countries of the European Economic Area (EEA) – i.e. All EU member states plus Iceland, Liechtenstein and Norway, Switzerland and Turkey.
No medical device can be placed on the market within Europe without a CE mark to one of the Medical Devices Directives or Regulations, even if the product is manufactured outside the EU.
What is the role of the Competent Authority?
Each country within the EU and partner countries has a Competent Authority. The Competent Authority is a body within the government of the Member States that transposes the requirements of the Medical Device Directives into National Law, and is responsible for ensuring law of the Regulation within their country.
The Competent Authority is also responsible for specifying one or more Notified Bodies, to act as independent third party assessors of the manufacturer’s compliance.
What is the Legal role of the Notified Body?
The role of a Notified Body is to conduct a conformity assessment under the relevant EU Directives or Regulations. The conformity assessment usually involves an audit of the manufacturer’s quality system and depending upon the particular classification of the device, a review of the relevant technical documentation provided by the manufacturer in support of the safety and performance claims for the device. The technical documentation is assessed against the Essential Requirements set out within the EU Directives or the General Safety and Performance Requirements (GSPRs) within the EU Regulations, and considers the relevant guidance set out by the EU.
Once the Notified Body has determined a manufacturer has conformed to the relevant assessment criteria, it issues a CE certificate to show that the products assessed meet the requirements.
The manufacturer then signs a Declaration of Conformity and applies the CE mark (with or without the Notified Body number).
What is the process a manufacturer has to go through to get a CE mark?
The route to follow for certification depends on the risk classification of the device.
- For Low risk Class I devices the manufacturer self-certifies ,applying the CE mark. If the device has a measuring capability or is supplied sterile, a Notified Body is however required. This will include reusable Class I devices under the MDR.
- For Class IIa (low to medium risk),Class IIb (medium to high risk) and Class I II(high risk) devices, a Notified Body audits the manufacturer’s quality system and the manufacturer requires a favourable audit to proceed to CE marking.
- For Class III devices a Notified Body evaluates the design of the medical device,by reviewing the technical documentation submitted by the manufacturer, and issues a certificate of conformity with the Regulation if it is satisfied with the device’s safety and performance data.
- AIMD,Active Implantable Medical Devices are regarded, by their very nature as high risk devices in terms of the AIMDD (90/385/EEC) and must undergo Full Quality Assurance including design of the product and post market surveillance. These devices will be classified as Class III devices under the MDR.
What does a Notified Body have to review as part of the legal assessment process?
From an EU regulatory perspective there are key requirements to meet, these are contained in the three EU Medical Devices Directives (MDD, AIMDD and IVDD) and the new Regulations (MDR and IVDR). The conformity assessment requires an on-site audit to be carried out of the manufacturer’s quality system or evidence of a current valid QMS certificate from a recognized Notified Body.
The CE process generally includes a Quality Management System (QMS) assessment. A comprehensive audit of the facility includes, reviewing the manufacturing process, systems, controls, material handling, microbiological & sterile systems etc. The audit is usually carried out to the standard ISO 13485 (the Medical Device QMS standard) and the ISO 13485 Certificate has a three year validity; as part of this process there is an annual surveillance audit to ensure conformity is maintained.
ISO 13485
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
Technical documentation is assessed against the requirements of the Directives or Regulations; it considers the standards, Common Specifications, and relevant guidance of the EC: European Commission (MEDDEV guidance).
The depth of the technical documentation review conducted by the Notified Body is dependent on the device’s risk classification.The manufacturer must provide all the technical documentation in support of the safety and performance claims for the device.
Does a Notified Body have to see the product as part of the certification process?
There are a number of conformity assessment procedures under the Directives and Regulations that a manufacturer can follow to CE mark a medical device. The CE process involves a Quality Management System (QMS) assessment that reviews the design, manufacture, inspection and test processes during which there will be direct involvement with the product.
Manufacturers of Annex II List A IVDs under the IVDD are required to have every batch of device released by the Notified Body, which may often require testing of the product. This will also apply to Class D devices, Class B-D self-tests/near patient tests, IVDs incorporating a medicinal substance or Companion Diagnostics under the IVDR.
The entry of data onto the European Database of Medical Devices (EUDAMED) is the responsibility of the Competent Authorities, notified bodies, economic operators and sponsors of systems referred to in Article 33 of the MDR and Article 30 of the IVDR.
Legality of Unannounced audits
Notified Bodies are required under EU legislation to perform unannounced audits of medical device manufacturers and related suppliers.
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